FDA-Device2025-06-18Class II
Azure S DR MRI SureScan, Product number W3DR01
Medtronic, Inc.
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.
Sold states
International distribution of the country of UK. No US distribution.
Affected count
6
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
Azure S DR MRI SureScan, Product number W3DR01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1924-2025Don't want to check this manually?
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