Azure S DR MRI SureScan, Product number W3DR01

FDA device recall Z-1924-2025 · posted 2025-06-06 · Open, Classified

Recall details

Recalling firm

Medtronic, Inc.

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.

Action taken

Firm notified consignees of the recall on April 29, 2025 via letters titled "Urgent Medical Device Recall". Customers were instructed to identify the affected product and return to Medtronic. If you have any questions regarding this communication, please contact your Medtronic Field Representative ***Updated 10/14/25*** Firm expanded action to include three implanted devices. Consignees were notified on September 29, 2025. Consignees were instructed to utilize the CareLink remote monitoring system and inform a Medtronic Representative if a return of patient symptoms occurs or any unexpected device behaviors occur, including but not limited to: device resets or unexpected pacing diagnostics, with or without an alert. If the clinician assesses that prophylactic replacement of the device is necessary, standard warranty will apply. Medtronic will provide a replacement Azure S DR and a TYRXTM absorbable antibacterial envelope at no cost.

Root cause

Process change control

Status

Open, Classified

Product code

NVZ

Quantity affected

6

Distribution

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

Date initiated

2025-04-29

Date posted

2025-06-06

Location

Mounds View, MN