Medtronic SmartLink Software loaded on SmartSync Patient Connector — Class II medical device recall Z-2127-2025
Ongoing recall by Medtronic, Inc., reported 2025-07-23. A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eli
| Recall number | Z-2127-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic, Inc., Mounds View, MN, United States |
| Recall initiated | 2025-06-17 |
| Classified | 2025-07-17 |
| Reported by FDA | 2025-07-23 |
| Quantity | 3,909 units |
| Reason classes | software |
| 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 SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7. Claria Amplia Compia application, Software Model Number D00U009; 8. Evera MRI application, Software Model Number D00U010; 9. Visia AF application, Software Model Number D00U011; 10. Viva Brava Evera application, Software Model Number D00U012; 11. Micra VR2 AV2 application, Software Model Number D00U022.
Reason for recall
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.
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-2127-2025. 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.