Medtronic recalls Azure XT SR MRI pacemakers (model W1SR01/W2SR01) due to rare temporary suspension of some device features during SmartSync Device Manager interrogation. Features restore after next interrogation or magnet presence. No serious injury risk.
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 certain Azure XT SR MRI pacemakers (model numbers W1SR01 and W2SR01) because a rare communication sequence during device interrogation with a SmartSync Device Manager may temporarily suspend some features like battery measurements and CRT therapy. This issue is unlikely to cause clinical impact to patients and features automatically restore after the next interrogation or when a magnet is present.
A rare communication sequence during the first device interrogation with a SmartSync Device Manager may temporarily suspend some device features (battery measurements, Capture Management, Atrial Lead Position Check, EffectivCRT algorithms, and AdaptivCRT). This suspension is unlikely to cause clinical impact to patients and features automatically restore after the next programmer device interrogation or when a magnet is present.
Patients with the recalled Azure XT SR MRI pacemakers (model numbers W1SR01 and W2SR01) are affected. The risk is low as the temporary suspension of features does not cause serious injury and features restore automatically.
Check if your device has model numbers W1SR01 or W2SR01. The recall includes specific serial numbers listed in the official notice.
Identify your device model by checking the label on the device or its packaging for model numbers W1SR01 or W2SR01.
No action is required as the temporary suspension of features automatically resolves after the next device interrogation or when a magnet is present. The recall is for information only.
The recall states the issue is unlikely to result in clinical impact to patients and does not cause serious injury. Features restore automatically.
Check if your device has model numbers W1SR01 or W2SR01 as listed in the official recall notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2509-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2509-2020 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.
