Percepta CRT-P MRI SureScan
Medical device recall Z-2414-2018. 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
- 1604 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 W1TR04 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.
1604 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN/UPN: (a) 00643169735699 Serial Numbers: RNU601594S RNU601595S RNU601596S RNU601115S RNU601438S RNU601430S RNU600949S RNU600950S RNU601300S RNU601302S RNU601451S RNU601453S RNU600517S RNU600582S RNU600629S RNU600664S RNU600665S…
Every code shown here, 1,992 characters
GTIN/UPN: (a) 00643169735699 Serial Numbers: RNU601594S RNU601595S RNU601596S RNU601115S RNU601438S RNU601430S RNU600949S RNU600950S RNU601300S RNU601302S RNU601451S RNU601453S RNU600517S RNU600582S RNU600629S RNU600664S RNU600665S RNU600666S RNU600684S RNU600735S RNU600736S RNU600737S RNU600738S RNU600739S RNU600740S RNU600741S RNU600742S RNU600743S RNU600744S RNU600746S RNU600747S RNU600997S RNU601014S RNU601503S RNU601575S RNU601577S RNU601640S RNU601641S RNU601642S RNU601643S RNU601644S RNU601645S RNU601646S RNU601647S RNU601648S RNU601649S RNU601650S RNU601651S RNU601652S RNU601653S RNU601654S RNU601655S RNU601656S RNU601657S RNU601658S RNU601659S RNU601660S RNU601661S RNU601662S RNU601663S RNU601664S RNU601665S RNU601666S RNU601667S RNU601668S RNU601669S RNU601670S RNU601671S RNU601672S RNU601673S RNU601674S RNU601675S RNU601676S RNU601678S RNU601679S RNU601680S RNU601681S RNU601682S RNU601683S RNU601684S RNU601685S RNU601686S RNU601687S RNU601688S RNU601689S RNU601691S RNU601692S RNU601693S RNU601694S RNU601695S RNU601696S RNU601697S RNU601698S RNU601699S RNU601700S RNU601701S RNU601702S RNU601703S RNU601704S RNU601705S RNU601708S RNU601709S RNU601711S RNU601712S RNU601713S RNU601714S RNU601716S RNU601717S RNU601719S RNU601720S RNU601723S RNU601724S RNU601726S RNU601727S RNU601729S RNU601731S RNU601732S RNU601733S RNU601734S RNU601735S RNU601736S RNU601738S RNU601739S RNU601740S RNU601741S RNU601743S RNU601753S RNU601754S RNU601755S RNU601756S RNU601757S RNU601758S RNU601759S RNU601760S RNU601761S RNU601762S RNU601763S RNU601764S RNU601765S RNU601766S RNU601767S RNU601768S RNU601769S RNU601770S RNU601771S RNU601772S RNU601773S RNU601774S RNU601775S RNU601776S RNU601777S RNU601778S RNU601780S RNU601781S RNU601783S RNU601782S RNU601439S RNU601440S RNU601441S RNU601442S RNU601443S RNU601444S RNU601445S RNU601446S RNU601447S RNU601448S RNU601449S RNU601457S RNU601458S RNU601459S RNU601460S RNU601461S RNU601462S RNU601463S RNU600715S RNU600722S RNU600732S…
FDA’s list runs to 17,722 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 17,722 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.