Azure S DR MRI
Medical device recall Z-2508-2020. 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
- 49513 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?
Azure S DR MRI, Model Number W3DR01
49513 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
serial numbers: RNJ200027H RNJ200025H RNJ200023H RNJ200022H RNJ200020H RNJ200018H RNJ200017H RNJ200015H RNJ200014H RNJ200011H RNJ200009H RNJ200008H RNJ200007H RNJ200006H RNJ200005H RNJ200004H RNJ200086H RNJ200085H RNJ200084H RNJ200083H…
Every code shown here, 1,996 characters
serial numbers: RNJ200027H RNJ200025H RNJ200023H RNJ200022H RNJ200020H RNJ200018H RNJ200017H RNJ200015H RNJ200014H RNJ200011H RNJ200009H RNJ200008H RNJ200007H RNJ200006H RNJ200005H RNJ200004H RNJ200086H RNJ200085H RNJ200084H RNJ200083H RNJ200082H RNJ200081H RNJ200080H RNJ200078H RNJ200077H RNJ200076H RNJ200075H RNJ200074H RNJ200073H RNJ200072H RNJ200071H RNJ200070H RNJ200069H RNJ200068H RNJ200067H RNJ200066H RNJ200064H RNJ200063H RNJ200062H RNJ200061H RNJ200060H RNJ200059H RNJ200058H RNJ200057H RNJ200056H RNJ200055H RNJ200054H RNJ200052H RNJ200051H RNJ200050H RNJ200049H RNJ200048H RNJ200047H RNJ200046H RNJ200045H RNJ200043H RNJ200041H RNJ200040H RNJ200039H RNJ200038H RNJ200037H RNJ200036H RNJ200035H RNJ200034H RNJ200033H RNJ200032H RNJ200031H RNJ200030H RNJ200029H RNJ200028H RNJ200145H RNJ200144H RNJ200143H RNJ200142H RNJ200141H RNJ200140H RNJ200139H RNJ200138H RNJ200137H RNJ200135H RNJ200134H RNJ200133H RNJ200131H RNJ200129H RNJ200128H RNJ200127H RNJ200126H RNJ200125H RNJ200124H RNJ200123H RNJ200122H RNJ200121H RNJ200120H RNJ200119H RNJ200118H RNJ200117H RNJ200116H RNJ200115H RNJ200114H RNJ200113H RNJ200112H RNJ200111H RNJ200110H RNJ200107H RNJ200105H RNJ200104H RNJ200103H RNJ200102H RNJ200101H RNJ200100H RNJ200098H RNJ200097H RNJ200096H RNJ200095H RNJ200093H RNJ200092H RNJ200091H RNJ200090H RNJ200089H RNJ200088H RNJ200087H RNJ204130H RNJ203325H RNJ200203H RNJ200202H RNJ200200H RNJ200199H RNJ200198H RNJ200197H RNJ200196H RNJ200195H RNJ200194H RNJ200193H RNJ200192H RNJ200191H RNJ200190H RNJ200189H RNJ200187H RNJ200186H RNJ200185H RNJ200184H RNJ200183H RNJ200182H RNJ200181H RNJ200180H RNJ200178H RNJ200177H RNJ200176H RNJ200175H RNJ200174H RNJ200173H RNJ200172H RNJ200171H RNJ200170H RNJ200169H RNJ200168H RNJ200167H RNJ200166H RNJ200165H RNJ200164H RNJ200163H RNJ200162H RNJ200160H RNJ200159H RNJ200158H RNJ200157H RNJ200156H RNJ200155H RNJ200154H RNJ200152H RNJ200151H RNJ200150H RNJ200149H RNJ200148H RNJ200147H RNJ200146H RNJ200439H RNJ200262H RNJ200261H RNJ200260H…
FDA’s list runs to 591,473 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 591,473 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.