Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967… Recall
Issued July 23, 2025 · Medtronic, Inc.
In July 2025, Medtronic, Inc. recalled the Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Medtronic, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Medtronic, Inc.
- Category
- Health
- Recall date
- July 23, 2025
- Units affected
- Not reported
- Sold at
- Worldwide
- Recall number
- FDA-Z-2127-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Medtronic, Inc. has 3 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.