Medical Device Recall: Azure S DR MRI SureScan, Product number W3DR01
Medtronic, Inc. · April 29, 2025
Reason for Recall
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.
Distribution
International distribution of the country of UK. No US distribution.
Quantity Affected
6
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1924-2025
Status: ongoing
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