Percepta CRT-P MRI
Medical device recall Z-2511-2020. Published in FDA’s Enforcement Report on Jul 15, 2020.
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 15, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 37360 devices 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?
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management”, Atrial Lead Position Check”, EffectivCRT” algorithms, and AdaptivCRT”). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
37360 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
a) W1TR01, serial numbers: RNO200006H RNO200023H RNO200029H RNO200036H RNO200038H RNO200041H RNO200044H RNO200048H RNO200050H RNO200051H RNO200064H RNO200070H RNO200086H RNO200088H RNO200096H RNO200105H RNO200109H RNO200110H RNO200136H…
Every code shown here, 1,996 characters
a) W1TR01, serial numbers: RNO200006H RNO200023H RNO200029H RNO200036H RNO200038H RNO200041H RNO200044H RNO200048H RNO200050H RNO200051H RNO200064H RNO200070H RNO200086H RNO200088H RNO200096H RNO200105H RNO200109H RNO200110H RNO200136H RNO200140H RNO200012H RNO200013H RNO200025H RNO200030H RNO200031H RNO200034H RNO200035H RNO200037H RNO200043H RNO200046H RNO200047H RNO200054H RNO200055H RNO200056H RNO200058H RNO200060H RNO200061H RNO200065H RNO200067H RNO200068H RNO200069H RNO200071H RNO200072H RNO200074H RNO200075H RNO200076H RNO200078H RNO200079H RNO200081H RNO200082H RNO200084H RNO200085H RNO200087H RNO200091H RNO200093H RNO200098H RNO200099H RNO200101H RNO200111H RNO200112H RNO200115H RNO200116H RNO200118H RNO200121H RNO200122H RNO200125H RNO200127H RNO200128H RNO200129H RNO200131H RNO200132H RNO200133H RNO200134H RNO200137H RNO200138H RNO200141H RNO200143H RNO200144H RNO200145H RNO200027H RNO200100H RNO200106H RNO200151H RNO200155H RNO200162H RNO200103H RNO200165H RNO200166H RNO200167H RNO200168H RNO200169H RNO200171H RNO200173H RNO200174H RNO200175H RNO200178H RNO200179H RNO200180H RNO200181H RNO200182H RNO200183H RNO200184H RNO200185H RNO200186H RNO200187H RNO200188H RNO200189H RNO200190H RNO200192H RNO200193H RNO200194H RNO200040H RNO200102H RNO200146H RNO200148H RNO200150H RNO200157H RNO200158H RNO200159H RNO200161H RNO200163H RNO200164H RNO200172H RNO200059H RNO200080H RNO200160H RNO200196H RNO200197H RNO200198H RNO200199H RNO200200H RNO200201H RNO200203H RNO200204H RNO200205H RNO200206H RNO200207H RNO200208H RNO200209H RNO200210H RNO200211H RNO200212H RNO200213H RNO200215H RNO200216H RNO200218H RNO200220H RNO200222H RNO200223H RNO200224H RNO200225H RNO200228H RNO200229H RNO200230H RNO200231H RNO200233H RNO200235H RNO200236H RNO200239H RNO200240H RNO200241H RNO200242H RNO200243H RNO200245H RNO200246H RNO200247H RNO200248H RNO200250H RNO200252H RNO200253H RNO200254H RNO200255H RNO200256H RNO200257H RNO200258H RNO200259H RNO200260H RNO200261H RNO200262H…
FDA’s list runs to 445,731 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
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 4, 2020.
- FDA classified it on Jul 5, 2020.
- FDA’s Enforcement Report published it on Jul 15, 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 445,731 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
-
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.