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Azure S DR MRI SureScan, Product number W3DR01

FDA Recall #Z-1924-2025 — Class II — April 29, 2025

Recall #Z-1924-2025 Date: April 29, 2025 Classification: Class II Status: Ongoing

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.

Recalling Firm

Medtronic, Inc. — Mounds View, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

6

Distribution

International distribution of the country of UK. No US distribution.

Code Information

Serial numbers RNJ108800G, RNJ108808G, RNJ108810G UDI-DI 00763000956004 ***Updated 10/14/25*** Scope expanded to include implanted devices, serial numbers: RNJ108803G RNJ108804G RNJ108820G

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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