Medtronic recalls CareLink SmartSync Device Manager for potential longevity estimation errors in early device life when unipolar pacing vectors are programmed. No other features affected.
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
Medtronic is recalling its CareLink SmartSync Device Manager for a possible error in estimating how long the device will last. This error could happen early in the device's life if certain pacing settings are programmed. The recall does not affect other device functions.
The device may incorrectly estimate its remaining lifespan when unipolar pacing vectors are set in the right atrial or ventricular leads during early device life. This could lead to unnecessary device replacement or missed treatment adjustments.
Patients using the CareLink SmartSync Device Manager for arrhythmias or heart failure treatment are affected. Those with unipolar pacing vectors programmed in the right atrial or ventricular leads are most at risk.
Check if your device has the model number 24970A for CareLink SmartSync Device Manager. The product is used for treating arrhythmias related to bradycardia or heart failure.
Verify if unipolar pacing vectors are programmed in the right atrial or ventricular leads.
No, the recall only affects CareLink SmartSync Device Manager with model number 24970A.
The official recall notice does not specify a remedy or action steps beyond checking device settings.
The recall states no other device features or therapies are impacted, so the risk is low.
We’ve drafted a message you can send Medtr: CareLink to request your refund or repair — edit it as you like.
Subject: Recall Z-1528-2021 — Medtr: CareLink Medtr: CareLink Hello, I own a Medtr: CareLink that is covered by recall Z-1528-2021 from Medtr: CareLink. 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.
