Medtronic is recalling Azure XT DR MRI devices with model numbers W1DR01 and W2DR01 due to a rare communication issue that may temporarily suspend device features during interrogation. Features restore after next programmer interaction or magnet presence. No patient 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 XT DR MRI devices with model numbers W1DR01 and W2DR01. A rare communication sequence during device interrogation with a SmartSync Device Manager may temporarily suspend some features like battery measurements and heart rhythm therapy adjustments. The issue is unlikely to cause patient harm and features automatically resume after the next device interrogation or when a magnet is present.
A rare communication sequence during the first device interrogation with a SmartSync Device Manager may temporarily suspend certain device features, including battery measurements, atrial lead position checks, and heart rhythm therapy adjustments. This temporary suspension does not cause patient harm and features automatically resume after the next device interrogation or when a magnet is present.
Patients with Medtronic Azure XT DR MRI devices (model numbers W1DR01 and W2DR01) who have the device implanted. The recall covers specific serial numbers listed in the official notice.
Check your device model number (W1DR01 or W2DR01) and serial numbers listed in the official recall notice. The recall covers specific serial numbers provided in the document.
Verify your device model number is W1DR01 or W2DR01 and check the serial numbers against the list provided in the recall notice.
The temporary suspension of features does not cause patient harm and will automatically resume after the next device interrogation or when a magnet is present.
No, the recall states the issue is unlikely to result in clinical impact to the patient. Features automatically resume after the next device interrogation or when a magnet is present.
No action is required. The temporary suspension of features does not cause patient harm and will automatically resume after the next device interrogation or when a magnet is present.
The recall affects Azure XT DR MRI devices with model numbers W1DR01 and W2DR01, and specific serial numbers listed in the official notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2507-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2507-2020 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.
