Medtronic CareLink SmartSync Patient Connector — Class II medical device recall Z-2168-2025
Ongoing recall by Medtronic, Inc., reported 2025-07-30, distributed nationwide. In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induct
| Recall number | Z-2168-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic, Inc., Mounds View, MN, United States |
| Recall initiated | 2025-06-18 |
| Classified | 2025-07-23 |
| Reported by FDA | 2025-07-30 |
| Distributed | Nationwide (US) |
| Quantity | 22,091 devices |
| UPC / GTIN / UDI-DI | 00763000002039, 00763000002046, 00763000002053, 00763000397852, 00763000397869, 00763000397876, 00763000397883, 00763000397890, 00763000397906, 00763000397913, 00763000544300 |
| Model numbers | 24967, D00U003, D00U004, D00U005, D00U006, D00U007, D00U008, D00U009, D00U010, D00U011, D00U012, D00U022 |
Product
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2168-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.