Recall archive / FDA device enforcement
Azure S DR MRI SureScan, Product number W3DR01 — FDA record Z-1924-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 29, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Medtronic, Inc.
- Quantity
- 6
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1924-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Serial numbers RNJ108800G, RNJ108808G, RNJ108810G UDI-DI 00763000956004 ***Updated 10/14/25*** Scope expanded to include implanted devices, serial numbers: RNJ108803G RNJ108804G RNJ108820G |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution of the country of UK. No US distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jun 18, 2025
- Recall initiation date
- Apr 29, 2025
- Center classification date
- Jun 6, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.