Solara CRT-P MRI
Medical device recall Z-2513-2020. 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
- 16667 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?
Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
16667 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
a) W1TR03, serial numbers: RNS200027H RNS200037H RNS200043H RNS200044H RNS200045H RNS200052H RNS200059H RNS200063H RNS200068H RNS200076H RNS200077H RNS200079H RNS200081H RNS200088H RNS200089H RNS200090H RNS200094H RNS200098H RNS200100H…
Every code shown here, 1,996 characters
a) W1TR03, serial numbers: RNS200027H RNS200037H RNS200043H RNS200044H RNS200045H RNS200052H RNS200059H RNS200063H RNS200068H RNS200076H RNS200077H RNS200079H RNS200081H RNS200088H RNS200089H RNS200090H RNS200094H RNS200098H RNS200100H RNS200005H RNS200007H RNS200016H RNS200020H RNS200022H RNS200025H RNS200026H RNS200028H RNS200030H RNS200032H RNS200033H RNS200034H RNS200038H RNS200042H RNS200050H RNS200051H RNS200054H RNS200060H RNS200061H RNS200064H RNS200065H RNS200067H RNS200071H RNS200072H RNS200074H RNS200080H RNS200082H RNS200084H RNS200085H RNS200086H RNS200087H RNS200091H RNS200093H RNS200099H RNS200101H RNS200053H RNS200104H RNS200109H RNS200111H RNS200116H RNS200118H RNS200019H RNS200040H RNS200092H RNS200035H RNS200102H RNS200103H RNS200105H RNS200107H RNS200108H RNS200110H RNS200113H RNS200115H RNS200117H RNS200119H RNS200120H RNS200121H RNS200122H RNS200123H RNS200125H RNS200126H RNS200127H RNS200048H RNS200128H RNS200130H RNS200140H RNS200124H RNS200129H RNS200143H RNS200144H RNS200131H RNS200138H RNS200132H RNS200136H RNS200137H RNS200133H RNS200134H RNS200135H RNS200148H RNS200149H RNS200150H RNS200151H RNS200154H RNS200155H RNS200156H RNS200158H RNS200159H RNS200160H RNS200161H RNS200162H RNS200163H RNS200164H RNS200165H RNS200167H RNS200168H RNS200169H RNS200170H RNS200171H RNS200172H RNS200173H RNS200174H RNS200175H RNS200176H RNS200177H RNS200178H RNS200179H RNS200181H RNS200185H RNS200193H RNS200194H RNS200195H RNS200196H RNS200198H RNS200199H RNS200202H RNS200203H RNS200204H RNS200206H RNS200207H RNS200210H RNS200212H RNS200213H RNS200214H RNS200215H RNS200216H RNS200217H RNS200220H RNS200223H RNS200224H RNS200226H RNS200227H RNS200228H RNS200230H RNS200232H RNS200182H RNS200183H RNS200186H RNS200191H RNS200200H RNS200205H RNS200229H RNS200231H RNS200142H RNS200218H RNS200233H RNS200234H RNS200235H RNS200236H RNS200237H RNS200239H RNS200240H RNS200243H RNS200245H RNS200246H RNS200247H RNS200248H RNS200251H RNS200252H RNS200253H RNS200255H…
FDA’s list runs to 197,407 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 197,407 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.