Reported Jun 18, 2025 · Ongoing
Azure S DR MRI SureScan, Product number W3DR01
Medtronic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic, Inc. · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
- Azure S DR MRI SureScan, Product number W3DR01
- Lot codes and dates
- Serial numbers RNJ108800G, RNJ108808G, RNJ108810G UDI-DI 00763000956004 ***Updated 10/14/25*** Scope expanded to include implanted devices
- serial numbersRNJ108803G RNJ108804G RNJ108820G
- Amount recalled
- 6
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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