Drug recall
Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the…
FDA recall event 97125 · Class II · Medtronic, Inc.
Key facts
| Event ID | 97125 |
|---|---|
| Recall numbers | Z-2127-2025, Z-2128-2025 |
| Recalling firm | Medtronic, Inc. |
| Product type | Devices |
| Products | Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2…, 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jun 17, 2025 |
| Report date | Jul 23, 2025 |
| City | Mounds View |
| State | MN |
| Country | United States |
| FEI number | 2182208 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: