Medtronic recalls Azure S SR MRI devices with specific serial numbers due to rare temporary suspension of device features during SmartSync Device Manager interrogation. Features restore automatically after next interrogation or magnet presence. No patient impact expected.
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 SR MRI devices with specific serial numbers because a rare communication issue during device interrogation can temporarily suspend certain features like battery measurements and heart therapy adjustments. This issue does not cause harm to patients and features automatically return after the next device check or when a magnet is present.
A rare communication sequence during device interrogation with a SmartSync Device Manager can temporarily suspend features like battery measurements and heart therapy adjustments. This temporary suspension does not cause harm and resolves automatically after the next device interrogation or when a magnet is present.
Patients with Azure S SR MRI devices (model W3SR01) and specific serial numbers listed in the recall. The issue is unlikely to affect patients as features automatically resume without requiring action.
Check if your device has the model number W3SR01 and one of the listed serial numbers (e.g., RNI200028H, RNI200029H). The recall includes 200+ serial numbers.
Identify your device's serial number to see if it's listed in the recall (e.g., RNI200028H, RNI200029H).
No, the temporary suspension of features does not cause harm. Features automatically return after the next device interrogation or when a magnet is present.
No action is needed. The issue resolves automatically without user intervention.
200+ devices with specific serial numbers (e.g., RNI200028H, RNI200029H) are affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2510-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2510-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
