Recall Z-0302-2027 ยท NVZ Pulse Generator, Permanent, Implantable
Medtronic, Inc.
CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable
| Date | Oct 27, 2026 (initiated Sep 24, 2026) |
| Status | Open, Classified |
| Reason | Software problem has the potential for an inaccurate displayed longevity estimate. |
| Root cause | Software design |
| Action | Medtronic issued a Communication regarding a software update to its consignees on 9/24/2026 via UPS 2-day delivery. The notice explained the issues and requested the consignees to update the SmartSync and return a confirmation certificate (or equivalent record) confirming they have received the notification and completed the action. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. For questions, contact Medtronic Technical Services at 800-638-1991 or the local Medtronic Sales |
| Quantity | 11238 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.