Medtronic, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1924-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Azure S DR MRI SureScan, Product number W3DR01

Product Classification:

Class II

Date Initiated: April 29, 2025

Date Posted: June 18, 2025

Recall Number: Z-1924-2025

Event ID: 96722

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.

Status: Ongoing

Product Quantity: 6

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated