Percepta Quad CRT-P MRI SureScan
Medical device recall Z-2415-2018. Published in FDA’s Enforcement Report on Jul 18, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 18, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 3560 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP).
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.
3560 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN/UPN: (a) 00643169735705 Serial Numbers: RNV601570S RNV601571S RNV601972S RNV603768S RNV603769S RNV603802S RNV602113S RNV603803S RNV603804S RNV603805S RNV603806S RNV603807S RNV603809S RNV603813S RNV603815S RNV603821S RNV603822S…
Every code shown here, 1,992 characters
GTIN/UPN: (a) 00643169735705 Serial Numbers: RNV601570S RNV601571S RNV601972S RNV603768S RNV603769S RNV603802S RNV602113S RNV603803S RNV603804S RNV603805S RNV603806S RNV603807S RNV603809S RNV603813S RNV603815S RNV603821S RNV603822S RNV603830S RNV603831S RNV603850S RNV603877S RNV603879S RNV603458S RNV603260S RNV603476S RNV603477S RNV603209S RNV603032S RNV602351S RNV603137S RNV603231S RNV603232S RNV602932S RNV602933S RNV602934S RNV602950S RNV602952S RNV602953S RNV602956S RNV602958S RNV602960S RNV602966S RNV602974S RNV602975S RNV602977S RNV603843S RNV603845S RNV601392S RNV601414S RNV601558S RNV601561S RNV601562S RNV601563S RNV601564S RNV601565S RNV601566S RNV601567S RNV601568S RNV601569S RNV601572S RNV601573S RNV601574S RNV601575S RNV601591S RNV601592S RNV601594S RNV601595S RNV601596S RNV601597S RNV601598S RNV601599S RNV601600S RNV601603S RNV601617S RNV601618S RNV601619S RNV601620S RNV601621S RNV601673S RNV601817S RNV601934S RNV601935S RNV601936S RNV601937S RNV601938S RNV601940S RNV601941S RNV601942S RNV601949S RNV601983S RNV601984S RNV601985S RNV601986S RNV601987S RNV601988S RNV601989S RNV601990S RNV601992S RNV601993S RNV601994S RNV601996S RNV601997S RNV601998S RNV601999S RNV602000S RNV602119S RNV602305S RNV602383S RNV603345S RNV603365S RNV603369S RNV603693S RNV603703S RNV603704S RNV603705S RNV603706S RNV603707S RNV603737S RNV603982S RNV603983S RNV603984S RNV603985S RNV603986S RNV603987S RNV603988S RNV603989S RNV603990S RNV603991S RNV603992S RNV603993S RNV603994S RNV603995S RNV603996S RNV603997S RNV603998S RNV603999S RNV604000S RNV604001S RNV604003S RNV604004S RNV604005S RNV604006S RNV604007S RNV604008S RNV604009S RNV604010S RNV604011S RNV604012S RNV602341S RNV601850S RNV602343S RNV602345S RNV602353S RNV602355S RNV602359S RNV603005S RNV603011S RNV603018S RNV603024S RNV603029S RNV603031S RNV603033S RNV603034S RNV603039S RNV603041S RNV603042S RNV603273S RNV603275S RNV603276S RNV603348S RNV602749S RNV603195S RNV603218S RNV603221S RNV603222S RNV603224S RNV603225S…
FDA’s list runs to 39,240 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US Nationwide
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 21, 2018.
- FDA classified it on Jul 10, 2018.
- FDA’s Enforcement Report published it on Jul 18, 2018.
- FDA terminated it on Aug 19, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), of Mounds View, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 39,240 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
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.” Copied on Oct 20, 2026.