Recall Z-1924-2025 ยท NVZ Pulse Generator, Permanent, Implantable
Medtronic, Inc.
Azure S DR MRI SureScan, Product number W3DR01
| Date | Jun 6, 2025 (initiated Apr 29, 2025) |
| Status | Open, Classified |
| Reason | 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 leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment. |
| Root cause | Process change control |
| Action | Firm notified consignees of the recall on April 29, 2025 via letters titled "Urgent Medical Device Recall". Customers were instructed to identify the affected product and return to Medtronic. If you have any questions regarding this communication, please contact your Medtronic Field Representative ***Updated 10/14/25*** Firm expanded action to include three implanted devices. Consignees were notified on September 29, 2025. Consignees were instructed to utilize the CareLink remote monitoring system and inform a Medtronic Representative if a return of patient symptoms occurs or any unexpec |
| Quantity | 6 |
| Distribution | International distribution of the country of UK. No US distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.