Medtronic recalls specific software versions of its CareLink SmartSync Device Manager (Model 24967A) due to a potential risk during high-voltage therapy tests where users may not be able to cancel therapy properly.
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
Medtronic is recalling certain software versions of its CareLink SmartSync Device Manager (Model 24967A) because older software versions had a bug that could prevent users from aborting high-voltage therapy tests. This could lead to unintended therapy delivery if the user tries to stop the test too late.
In older software versions, the Abort button stopped the test that was selected, but during an induction test there was a limited window of time for the user to abort a therapy. This could limit the user's ability to cancel a high voltage therapy delivery if they tried to stop it too late.
Users of the Medtronic CareLink SmartSync Device Manager with Model Number 24967A and specific software versions listed in the recall notice are affected. Patients using this device for cardiac monitoring are most at risk.
Check if your CareLink SmartSync Device Manager has Model Number 24967A and the specific software versions listed in the recall notice, including software model numbers D00U003 through D00U012 with corresponding updated versions.
Install the latest software updates listed in the recall notice to fix the issue with the Abort button functionality.
No, the recall does not require immediate discontinuation of use. Updating the software resolves the issue.
Software versions D00U003 through D00U012 with specific updated versions are affected, as listed in the recall notice.
Check your CareLink SmartSync Device Manager's model number (24967A) and software versions 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-2169-2025 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2169-2025 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.
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.
