Azure S DR MRI — Class II medical device recall Z-2508-2020
Ongoing recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2020-07-15. There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager t
| Recall number | Z-2508-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2020-06-04 |
| Classified | 2020-07-05 |
| Reported by FDA | 2020-07-15 |
| Quantity | 49,513 devices |
| Serial numbers | RNJ200004H, RNJ200005H, RNJ200006H, RNJ200007H, RNJ200008H, RNJ200009H, RNJ200011H, RNJ200014H, RNJ200015H, RNJ200017H, RNJ200018H, RNJ200020H, RNJ200022H, RNJ200023H, RNJ200025H, RNJ200027H, RNJ200028H, RNJ200029H, RNJ200030H, RNJ200031H, RNJ200032H, RNJ200033H, RNJ200034H, RNJ200035H, RNJ200036H and 475 more |
| Model numbers | W3DR01 |
Product
Azure S DR MRI, Model Number W3DR01
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.