Serena CRT-P MRI
Medical device recall Z-2512-2020. 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
- 17750 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?
Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
17750 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
a) W1TR02, serial numbers: RNQ200008H RNQ200032H RNQ200035H RNQ200043H RNQ200045H RNQ200049H RNQ200051H RNQ200052H RNQ200057H RNQ200059H RNQ200061H RNQ200074H RNQ200076H RNQ200080H RNQ200096H RNQ200100H RNQ200102H RNQ200107H RNQ200109H…
Every code shown here, 1,996 characters
a) W1TR02, serial numbers: RNQ200008H RNQ200032H RNQ200035H RNQ200043H RNQ200045H RNQ200049H RNQ200051H RNQ200052H RNQ200057H RNQ200059H RNQ200061H RNQ200074H RNQ200076H RNQ200080H RNQ200096H RNQ200100H RNQ200102H RNQ200107H RNQ200109H RNQ200110H RNQ200111H RNQ200130H RNQ200132H RNQ200133H RNQ200003H RNQ200005H RNQ200006H RNQ200007H RNQ200010H RNQ200011H RNQ200017H RNQ200018H RNQ200020H RNQ200022H RNQ200025H RNQ200028H RNQ200029H RNQ200031H RNQ200033H RNQ200034H RNQ200036H RNQ200039H RNQ200040H RNQ200050H RNQ200054H RNQ200056H RNQ200060H RNQ200062H RNQ200064H RNQ200065H RNQ200067H RNQ200071H RNQ200072H RNQ200075H RNQ200077H RNQ200078H RNQ200081H RNQ200085H RNQ200088H RNQ200091H RNQ200093H RNQ200098H RNQ200103H RNQ200105H RNQ200108H RNQ200115H RNQ200116H RNQ200119H RNQ200120H RNQ200123H RNQ200124H RNQ200125H RNQ200126H RNQ200128H RNQ200131H RNQ200135H RNQ200137H RNQ200141H RNQ200145H RNQ200146H RNQ200147H RNQ200152H RNQ200154H RNQ200157H RNQ200158H RNQ200162H RNQ200167H RNQ200168H RNQ200169H RNQ200171H RNQ200174H RNQ200012H RNQ200134H RNQ200136H RNQ200139H RNQ200140H RNQ200183H RNQ200149H RNQ200150H RNQ200159H RNQ200160H RNQ200163H RNQ200176H RNQ200178H RNQ200179H RNQ200180H RNQ200181H RNQ200186H RNQ200188H RNQ200189H RNQ200198H RNQ200199H RNQ200206H RNQ200210H RNQ200217H RNQ200229H RNQ200234H RNQ200238H RNQ200245H RNQ200247H RNQ200248H RNQ200249H RNQ200196H RNQ200202H RNQ200204H RNQ200212H RNQ200221H RNQ200230H RNQ200235H RNQ200244H RNQ200191H RNQ200200H RNQ200203H RNQ200233H RNQ200192H RNQ200193H RNQ200194H RNQ200195H RNQ200208H RNQ200215H RNQ200231H RNQ200241H RNQ200302H RNQ200246H RNQ200274H RNQ200275H RNQ200280H RNQ200281H RNQ200282H RNQ200283H RNQ200284H RNQ200285H RNQ200286H RNQ200287H RNQ200303H RNQ200307H RNQ200272H RNQ200278H RNQ200292H RNQ200251H RNQ200255H RNQ200259H RNQ200261H RNQ200262H RNQ200265H RNQ200266H RNQ200300H RNQ200250H RNQ200256H RNQ200258H RNQ200263H RNQ200267H RNQ200277H RNQ200254H RNQ200260H RNQ200264H RNQ200269H RNQ200291H RNQ200374H…
FDA’s list runs to 210,404 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 210,404 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.