Medtronic, Inc. recalls Azure S DR MRI SureScan, Product number W3DR01

Recall date

April 29, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1924-2025

FDA classification

Class II

Brand / firm

Medtronic, Inc.

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Azure S DR MRI SureScan, Product number W3DR01