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Medtronic, Inc. recalls Azure S DR MRI SureScan, Product number W3DR01
Recalled June 18, 2025 · FDA recall Z-1924-2025 · Medtronic
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. · FDA Class II
Units
6
Sold at
International distribution of the country of UK. No US distribution.
Description
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.
Product
Azure S DR MRI SureScan, Product number W3DR01
Manufacturer(s)
Medtronic, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →