Medtronic Solara CRT-P MRI devices with model numbers W1TR03, W1TR06, W4TR03, W4TR06 may temporarily suspend device features during device interrogation. Features restore after next programmer interrogation or magnet presence. No clinical 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 Solara CRT-P MRI devices with specific model numbers may temporarily suspend certain device features during device interrogation. This is unlikely to cause clinical issues and features automatically resume 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 CRT therapy adjustments. This suspension is temporary and resolves automatically after the next device check or when a magnet is present.
Patients with Medtronic Solara CRT-P MRI devices using the listed model numbers are affected. The risk is minimal as the issue does not cause clinical harm and features return to normal.
Check your device's model number (W1TR03, W1TR06, W4TR03, or W4TR06) and serial number against the provided list. The recall includes specific serial numbers listed in the record.
Identify your device's model number (W1TR03, W1TR06, W4TR03, or W4TR06) and compare it to the list of affected models.
Check your device's serial number against the provided list of affected serial numbers to confirm if it is recalled.
No clinical impact is expected. The temporary suspension of features does not cause harm and features automatically resume after the next device interrogation or when a magnet is present.
No action is required. The issue is temporary and features will resume normally without any intervention.
Check your device's model number (W1TR03, W1TR06, W4TR03, or W4TR06) and serial number against the provided list of affected models and serial numbers.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2513-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2513-2020 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.
