Percepta CRT-P MRI SureScan
Medical device recall Z-2412-2018. 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
- 1842 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 CRT-P MRI SureScan, REF W1TR01 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.
1842 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN/UPN: (a) 00643169735637 Serial Numbers: RNO201997H RNO202010H RNO202012H RNO202015H RNO202016H RNO202018H RNO202045H RNO202049H RNO202050H RNO202051H RNO202055H RNO202056H RNO202058H RNO202062H RNO202065H RNO202067H RNO202068H…
Every code shown here, 1,992 characters
GTIN/UPN: (a) 00643169735637 Serial Numbers: RNO201997H RNO202010H RNO202012H RNO202015H RNO202016H RNO202018H RNO202045H RNO202049H RNO202050H RNO202051H RNO202055H RNO202056H RNO202058H RNO202062H RNO202065H RNO202067H RNO202068H RNO202069H RNO202072H RNO202075H RNO202078H RNO202083H RNO202086H RNO202087H RNO202088H RNO202092H RNO202093H RNO202094H RNO202098H RNO202099H RNO202100H RNO202101H RNO201399H RNO201985H RNO201986H RNO201989H RNO201990H RNO201994H RNO201988H RNO201995H RNO202048H RNO202090H RNO202091H RNO202011H RNO201962H RNO201966H RNO201967H RNO201970H RNO201974H RNO201977H RNO201978H RNO201980H RNO201982H RNO202013H RNO202014H RNO202017H RNO202019H RNO202037H RNO202040H RNO202042H RNO202073H RNO202079H RNO202009H RNO201922H RNO201981H RNO202034H RNO200663H RNO201582H RNO201603H RNO200042H RNO200092H RNO200202H RNO200455H RNO200550H RNO200583H RNO201033H RNO201133H RNO201837H RNO201923H RNO201925H RNO201928H RNO201930H RNO201934H RNO201936H RNO201938H RNO201939H RNO201940H RNO201944H RNO201945H RNO201947H RNO201948H RNO201950H RNO201952H RNO201953H RNO201956H RNO201960H RNO201968H RNO201969H RNO201971H RNO201973H RNO200252H RNO200269H RNO201907H RNO201912H RNO201913H RNO201918H RNO201920H RNO201924H RNO201935H RNO201946H RNO201904H RNO200829H RNO200809H RNO200823H RNO200087H RNO201066H RNO201821H RNO201358H RNO200859H RNO201768H RNO201082H RNO200571H RNO200547H RNO201286H RNO200520H RNO201181H RNO201431H RNO200544H RNO201490H RNO200860H RNO201019H RNO200977H RNO200414H RNO200864H RNO200499H RNO201424H RNO201574H RNO201813H RNO201308H RNO201751H RNO201333H RNO201794H RNO201487H RNO200097H RNO201743H RNO200480H RNO201411H RNO201330H RNO200399H RNO200759H RNO201804H RNO201707H RNO201460H RNO200738H RNO201463H RNO201024H RNO200528H RNO200281H RNO201770H RNO200412H RNO201070H RNO201724H RNO201937H RNO201831H RNO200256H RNO201818H RNO200526H RNO201758H RNO201858H RNO201864H RNO201641H RNO200772H RNO201558H RNO201884H RNO200153H RNO200646H RNO200845H…
FDA’s list runs to 20,340 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 20,340 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.