Medtronic recalls Serena CRT-P MRI devices with specific model numbers and serials for a rare temporary suspension of device features during SmartSync Device Manager interrogation. Features restore automatically after next interrogation or magnet presence.
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 models of Serena CRT-P MRI devices due to a rare temporary suspension of certain device features during device interrogation with a SmartSync Device Manager. This issue does not cause clinical impact to patients and features automatically resume after the next interrogation or when a magnet is present.
During the first device interrogation with a SmartSync Device Manager, a rare communication sequence may temporarily suspend device features like battery measurements and CRT therapy algorithms. This suspension is temporary and does not cause clinical harm to patients.
Patients with Medtronic Serena CRT-P MRI devices matching the listed model numbers or serial numbers are affected. The risk is very low as the issue is rare and does not cause clinical harm.
Check your device model numbers: W1TR02, W1TR05, or W4TR02, W4TR05. Also check your serial numbers against the list provided in the recall notice.
Verify your device model number (W1TR02, W1TR05, W4TR02, or W4TR05) and serial number against the list provided in the recall notice.
No, the issue is rare and does not cause clinical impact to patients. Features automatically resume after the next interrogation or when a magnet is present.
No action is required as the issue is temporary and features will resume automatically. Check your device model and serial numbers to confirm if it's affected.
Check your device model number (W1TR02, W1TR05, W4TR02, or W4TR05) and serial number against the list 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-2512-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2512-2020 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.
