Agency classClass IIOur severity:Severe FDA (Devices)·Z-1924-2025·Announced 2025-06-18

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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.
Category: Medical Device — Pacemaker / Cardiac Device
Hazard: battery-failure
cardiac-arrest
therapy-interruption
Affected units: 6

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.

Same manufacturer · Medtronic, Inc.

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