Azure S DR MRI SureScan Pacemakers Recalled for Battery Failure Risk
Medtronic Azure S DR MRI SureScan pacemakers may experience sudden battery power failure without warning, potentially interrupting therapy and leading to cardiac arrest or hospitalization. Affected devices are being recalled internationally.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text describes potential for cardiac arrest and hospitalization, and the recall is FDA Class II. Class II recalls with reported potential for serious injury or hospitalization meet the "Severe" criterion per the rubric.
Plain-English summary
Medtronic, Inc. is recalling Azure S DR MRI SureScan pacemakers (Product number W3DR01) due to a risk of sudden battery power failure without alarm. Affected devices may also experience power supply resets and interruption of therapy delivery.
The recalled devices are identified by specific serial numbers: RNJ108800G, RNJ108808G, RNJ108810G, RNJ108803G, RNJ108804G, and RNJ108820G (UDI-DI 00763000956004). The devices have been distributed internationally in the United Kingdom. No distribution to the United States has been reported.
Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization. Patients requiring system revision (removal and replacement) face additional risks including infection, hematoma, or temporary impairment.
Patients with an Azure S DR MRI SureScan pacemaker should contact their healthcare provider or Medtronic immediately if they have questions or concerns about their device.
The recalled product
- Product
- Azure S DR MRI SureScan, Product number W3DR01
- Manufacturer
- Medtronic, Inc.
- Hazard
- battery-failure
- cardiac-arrest
- therapy-interruption
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Serial numbers RNJ108800G
- RNJ108808G
- serial numbers: RNJ108803G RNJ108804G RNJ108820G
Distribution
Distribution scope not specified by the agency.
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