Recall Z-1924-2025— Medtronic, Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic, Inc., initiated 2025-04-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Azure S DR MRI SureScan, Product number W3DR01. 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..
- Recalling firm
- Medtronic, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-29
- Firm location
- Mounds View, MN, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.