Medtronic recalls CareLink SmartSync Device Manager Model 24970A with serial numbers SPM001078A through SPM011821A. A rare communication sequence during initial device interrogation may temporarily suspend certain features like battery measurements and CRT therapy adjustments, but features restore automatically after next interrogation or magnet presence. No serious injury 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 CareLink SmartSync Device Manager Model 24970A with specific serial numbers. A rare communication issue during the first device check can temporarily pause some features like battery measurements and heart therapy adjustments, but these functions automatically return after the next check or when a magnet is present. This is unlikely to cause harm to patients.
A rare communication sequence during the initial device interrogation may temporarily suspend certain features such as battery measurements, Capture Management, Atrial Lead Position Check, and CRT therapy algorithms. These features automatically resume after the next device interrogation or when a magnet is present, so no serious injury risk is expected.
Patients using the CareLink SmartSync Device Manager Model 24970A with the listed serial numbers are affected. The risk is minimal as the temporary suspension of features resolves itself without requiring action.
Check your CareLink SmartSync Device Manager for the model number 24970A and the serial numbers listed in the recall (SPM001078A through SPM011821A).
Identify your CareLink SmartSync Device Manager's serial number to confirm if it's in the recall list.
No, the recall states the temporary suspension of features does not result in clinical impact to patients and features automatically return after next interrogation or magnet presence.
No action is required as the temporary suspension of features resolves itself automatically without user intervention.
Check your CareLink SmartSync Device Manager's serial number against the list of affected serial numbers (SPM001078A through SPM011821A).
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2505-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2505-2020 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.
