Official recall record
Azure S DR MRI SureScan, Product number W3DR01
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-04-29
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00763000956004
- Brand on record
- Medtronic, Inc.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-03-11 · US FDA — Medical Devices
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment o - 2025-06-18 · US FDA — Medical Devices
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: - 2025-06-18 · US FDA — Medical Devices
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1.
All 6 official recall notices naming Medtronic, Inc. on this site →
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