Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall ICD-DR DDBB1D1 EVERA XT IS1/DF1 US There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-DR DDBB1D4 EVERA XT IS1/DF4 US There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD EVERA XT DR GOLD CTD There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-DR DDMB1D1 EVERA MRI XT US DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-DR DDMB2D1 EVERA MRI XT OUS DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-DR DDMD3D1 PRIMO MRI There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-DR DDMD3D4 PRIMO MRI There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-DR DDME3D1 MIRRO MRI There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD-DR DDME3D4 MIRRO MRI There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD COBALT XT DR MRI IS1 DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD COBALT XT DR MRI IS1 DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD COBALT DR MRI IS1 DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD COBALT DR MRI IS1 DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD CROME DR MRI IS1 DF1 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ICD CROME DR MRI IS1 DF4 There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBA1D1 VIVA XT IS1/DF1 US There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBA1D1G DF1 VIVA XT US GOLD CTD There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBA1D4 VIVA XT IS1/DF4 US There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD VIVA QUAD XT CUST PARY GOLD There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D VIVA QUAD XT GOLD CTD There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBB1D1 VIVA S IS1/DF1 US There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBB1D4 VIVA S IS1/DF4 US There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBB2D1 VIVA S IS1/DF1 INTL There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBB2D4 VIVA S IS1/DF4 INTL There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBC2D1 BRAVA IS1/DF1 INTL There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBC2D4 BRAVA IS1/DF4 INTL There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusOngoingWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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