FDA Device recall Z-1924-2025
Azure S DR MRI SureScan, Product number W3DR01
- FDA Device
- Class II
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of Azure S DR MRI SureScan, Product number W3DR01 by Medtronic, citing identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficie….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1924-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-29 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic |
| Distribution | n/a |
Product
Azure S DR MRI SureScan, Product number W3DR01
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.
Identifiers
| code_info | Serial numbers RNJ108800G, RNJ108808G, RNJ108810G UDI-DI 00763000956004 ***Updated 10/14/25*** Scope expanded to incl…Serial numbers RNJ108800G, RNJ108808G, RNJ108810G UDI-DI 00763000956004 ***Updated 10/14/25*** Scope expanded to include implanted devices, serial numbers: RNJ108803G RNJ108804G RNJ108820G |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1924-2025%22
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