FDAFDA · Food and drugs·Recall number Z-1924-2025
Azure S DR MRI SureScan, Product number W3DR01
Published June 18, 2025 · Recall initiated: April 29, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic, Inc.
- Distributor
- International distribution of the country of UK. No US distribution.
- Lot
- Serial numbers RNJ108800G, RNJ108808G, RNJ108810G UDI-DI 00763000956004 ***Updated 10/14/25*** Scope expanded to include implanted devices, serial numbers: RNJ108803G RNJ108804G RNJ108820G
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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