Medtronic recalls specific software versions for CareLink SmartSync Device Manager to prevent false electrical reset alerts that could lead to unnecessary device explant.
A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.
Medtronic is recalling specific software versions for its CareLink SmartSync Device Manager that may display a false electrical reset message. This could cause clinicians to mistakenly remove the device, though no actual harm occurred in reported cases.
The software may show a false electrical reset message, causing clinicians to believe a reset has occurred when it hasn't. This could lead to unnecessary device explant procedures if the message is mistaken for a real issue.
Patients using Medtronic's CareLink SmartSync Device Manager with the specified software versions are affected. Clinicians who rely on the device for monitoring are most at risk of unnecessary device removal.
Check if your CareLink SmartSync Device Manager has software versions D00U003 through D00U022 listed in the recall notice. The device model number is 24967A.
Verify your device's software version by checking the model numbers listed in the recall notice.
No, the recall addresses a false message that could cause unnecessary device removal, but no actual harm occurred in reported cases.
Check if your CareLink SmartSync Device Manager has software versions D00U003 through D00U022 with model number 24967A.
You do not need to take action unless you have the recalled software versions; no remedy is provided.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2128-2025 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2128-2025 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.
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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.
