Azure S DR MRI SureScan, Product number W3DR01
Reported: June 18, 2025 Initiated: April 29, 2025 #Z-1924-2025
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.
Details
- Recalling Firm
- Medtronic, Inc.
- Units Affected
- 6
- Distribution
- International distribution of the country of UK. No US distribution.
- Location
- Mounds View, MN
Frequently Asked Questions
What product was recalled? ▼
Azure S DR MRI SureScan, Product number W3DR01. Recalled by Medtronic, Inc.. Units affected: 6.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 18, 2025. Severity: Moderate. Recall number: Z-1924-2025.
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