Drug recall
Azure S DR MRI SureScan, Product number W3DR01
FDA recall event 96722 · Class II · Medtronic, Inc.
Key facts
| Event ID | 96722 |
|---|---|
| Recall numbers | Z-1924-2025 |
| Recalling firm | Medtronic, Inc. |
| Product type | Devices |
| Products | Azure S DR MRI SureScan, Product number W3DR01 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support… |
| Initiation date | Apr 29, 2025 |
| Report date | Jun 18, 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: