Percepta Quad CRT-P MRI SureScan
Medical device recall Z-2413-2018. 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
- 6712 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 W4TR01 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.
6712 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN/UPN: (a) 00643169735644 Serial Numbers: RNP202329H RNP206542H RNP204079H RNP204773H RNP204816H RNP206419H RNP206432H RNP206445H RNP206456H RNP206491H RNP206511H RNP206515H RNP206522H RNP206527H RNP206528H RNP206531H RNP206541H…
Every code shown here, 1,992 characters
GTIN/UPN: (a) 00643169735644 Serial Numbers: RNP202329H RNP206542H RNP204079H RNP204773H RNP204816H RNP206419H RNP206432H RNP206445H RNP206456H RNP206491H RNP206511H RNP206515H RNP206522H RNP206527H RNP206528H RNP206531H RNP206541H RNP206545H RNP206550H RNP206551H RNP206552H RNP206555H RNP206560H RNP206561H RNP206568H RNP206576H RNP206577H RNP206578H RNP206580H RNP206581H RNP206586H RNP206587H RNP206574H RNP206595H RNP206598H RNP206579H RNP206606H RNP206610H RNP206582H RNP206584H RNP206585H RNP206611H RNP206614H RNP206588H RNP206615H RNP206590H RNP206591H RNP206592H RNP206593H RNP206616H RNP206596H RNP206597H RNP206618H RNP206599H RNP206601H RNP206602H RNP206605H RNP206627H RNP206629H RNP206630H RNP206612H RNP206635H RNP206638H RNP206639H RNP206640H RNP206620H RNP206621H RNP206622H RNP206641H RNP206643H RNP206647H RNP206631H RNP206632H RNP206633H RNP206655H RNP206660H RNP206663H RNP206664H RNP206642H RNP206674H RNP206675H RNP206651H RNP206682H RNP206690H RNP206661H RNP206693H RNP206707H RNP206710H RNP206711H RNP206678H RNP206712H RNP206716H RNP206688H RNP206719H RNP206725H RNP206734H RNP206769H RNP206773H RNP206775H RNP206776H RNP206176H RNP206338H RNP206415H RNP206416H RNP206417H RNP206418H RNP206420H RNP206421H RNP206423H RNP206424H RNP206430H RNP206431H RNP206433H RNP206435H RNP206441H RNP206442H RNP206443H RNP206444H RNP206447H RNP206448H RNP206450H RNP206452H RNP206453H RNP206455H RNP206459H RNP206460H RNP206461H RNP206462H RNP206463H RNP206464H RNP206465H RNP206467H RNP206468H RNP206469H RNP206470H RNP206473H RNP206475H RNP206478H RNP206479H RNP206481H RNP206482H RNP206485H RNP206486H RNP206487H RNP206488H RNP206489H RNP206490H RNP206493H RNP206496H RNP206497H RNP206498H RNP206501H RNP206502H RNP206503H RNP206504H RNP206505H RNP206506H RNP206508H RNP206509H RNP206510H RNP206512H RNP206513H RNP206514H RNP206517H RNP206521H RNP206523H RNP206524H RNP206525H RNP206526H RNP206529H RNP206530H RNP206533H RNP206534H RNP206535H RNP206537H RNP206538H RNP206539H…
FDA’s list runs to 73,913 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 73,913 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.