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Recall Observatory FDA recall evidence

Device product

Azure S DR MRI SureScan, Product number W3DR01

Z-1924-2025

April 29, 2025

Class II

Product summary

Firm
Medtronic, Inc.
Event
Event 96722
Status
Ongoing
Classification
Class II
Quantity
6
Official record key
device-enforcement:Z-1924-2025

Official wording

Reason: 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.

Code information: Serial numbers RNJ108800G, RNJ108808G, RNJ108810G UDI-DI 00763000956004 ***Updated 10/14/25*** Scope expanded to include implanted devices, serial numbers: RNJ108803G RNJ108804G RNJ108820G

Distribution pattern: International distribution of the country of UK. No US distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.