Medtronic CareLink SmartSync Device Manager software may display inaccurate remaining longevity estimates for certain implanted cardiac devices. This does not affect device functionality but could lead to incorrect battery life predictions.
There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality.
Medtronic's CareLink SmartSync Device Manager software may show incorrect battery life estimates for some implanted cardiac devices. This issue does not cause device malfunction but could lead to inaccurate predictions about how long the device will last.
The software may display an inaccurate remaining longevity estimate for a subset of implanted cardiac devices. This could lead to incorrect predictions about battery life, but the device itself continues to function normally.
Owners of Medtronic implanted cardiac devices using the CareLink SmartSync Device Manager software with specific serial numbers listed in the recall. Most users are not at risk as the issue does not impact device functionality.
Check if your CareLink SmartSync Device Manager software has a serial number starting with SPM001018A through SPM004334A (the full list of serial numbers is provided in the recall).
Identify your CareLink SmartSync Device Manager software's serial number to see if it matches the list of affected serial numbers provided in the recall.
No, the issue only affects the software's display of remaining longevity estimates. The device continues to function normally.
Check the serial number on your CareLink SmartSync Device Manager software. If it starts with SPM001018A through SPM004334A (the full list is provided in the recall), it is affected.
No action is required as the issue does not impact device functionality. However, you should check your software's serial number to confirm if it is affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0241-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0241-2020 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.
