FDA recall Z-1924-2025

Medtronic, Inc. · Class II · device

Product

Azure S DR MRI SureScan, Product number W3DR01

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.

Key facts

Status: Ongoing
Initiation date: 2025-04-29
Report date: 2025-06-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1924-2025