Medtronic, Inc.: Pulse Generator, Permanent, Implantable
Recall Summary Medtronic is recalling the CareLink SmartSync Device Manager App (Model M01A02), a software application used with implantable pulse generators, because a software problem may cause the longevity estimate displayed to patients to be inaccurate. The app is distributed worldwide. This is classified as a Class III recall, indicating the problem is unlikely to cause serious health consequences.
- Recalling firm
- Medtronic, Inc.
- Product
- CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable
- Reason
- Software problem has the potential for an inaccurate displayed longevity estimate.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-24
- Status
- Open, Classified
- Distribution
- Worldwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/d21a8a50-e7ad-4116-a08b-a1cba2628daa