Medtronic recalls Azure S DR MRI devices (model W3DR01) with serial numbers listed. A rare communication issue may temporarily suspend device features during SmartSync Device Manager interrogation, but features restore automatically after next interrogation or magnet presence. No serious injury risk reported.
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.
Medtronic is recalling Azure S DR MRI devices (model W3DR01) with specific serial numbers. A rare communication sequence during device interrogation with a SmartSync Device Manager may temporarily suspend some features like battery measurements and CRT therapy adjustments. However, these features automatically resume after the next interrogation or when a magnet is present, and the recall does not pose a serious injury risk.
A rare communication sequence during the first device interrogation with a SmartSync Device Manager can temporarily suspend certain device features, including battery measurements, capture management, atrial lead position checks, and CRT therapy algorithms. This suspension occurs but is temporary and resolves automatically after the next interrogation or when a magnet is present.
Patients with Medtronic Azure S DR MRI devices (model W3DR01) with the listed serial numbers are affected. The risk is minimal as the issue is rare and features automatically resume without patient action.
Check if your device has the model number W3DR01 and one of the listed serial numbers (e.g., RNJ200027H, RNJ200025H, etc.). The recall covers specific serial numbers provided in the official notice.
Identify your device's serial number to see if it's listed in the recall notice.
No, the recall states the issue is unlikely to result in clinical impact to the patient and features automatically resume without causing serious injury.
Check if your device has the model number W3DR01 and one of the specific serial numbers listed in the recall notice.
No action is required as the temporary suspension of features automatically resolves after the next device interrogation or when a magnet is present.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2508-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2508-2020 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
