Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Azure S DR MRI SureScan Recalled by Medtronic, Inc. Due to Identified devices may experience sudden battery power failure...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic, Inc. directly.
Affected Products
Azure S DR MRI SureScan, Product number W3DR01
Quantity: 6
Why Was This 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.
Where Was This Sold?
International distribution of the country of UK. No US distribution.
About Medtronic, Inc.
Medtronic, Inc. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report