Medtronic recalls Percepta CRT-P MRI devices with specific model numbers due to a rare temporary suspension of device features during certain device interrogations. Features automatically resume 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 specific Percepta CRT-P MRI devices that may temporarily suspend certain features during device interrogations. This issue is unlikely to affect patient care 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 can temporarily suspend features like battery measurements and CRT therapy adjustments. This suspension resolves automatically after the next interrogation or when a magnet is present, so it does not cause harm.
Patients with Medtronic Percepta CRT-P MRI devices matching the listed model numbers and serial numbers are affected. The risk is minimal as the issue is temporary and does not impact patient care.
Check your Percepta CRT-P MRI device's model numbers (W1TR01, W1TR04, W4TR01, W4TR04) and serial numbers listed in the recall notice. The recall covers specific serial numbers provided in the record.
Verify your Percepta CRT-P MRI device's model number (W1TR01, W1TR04, W4TR01, or W4TR04) and serial number against the list provided in the recall notice.
No, the temporary suspension of features does not cause harm. The issue resolves automatically after the next device interrogation or when a magnet is present, and there is no expected clinical impact.
No action is required. The device will automatically resume normal functions after the next interrogation or magnet presence. No repairs or replacements are needed.
Check your device's model number (W1TR01, W1TR04, W4TR01, or W4TR04) and serial number against the list of affected serial numbers provided in the 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-2511-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2511-2020 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.
