—#213459

Product

Azure S DR MRI SureScan, Product number W3DR01

FDA product code: NVZ — Pulse Generator, Permanent, Implantable
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P980035
Affected lot / code info: Serial numbers RNJ108800G, RNJ108808G, RNJ108810G UDI-DI 00763000956004 ***Updated 10/14/25*** Scope expanded to include implanted devices, serial numbers: RNJ108803G RNJ108804G RNJ108820G

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.

Root cause (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: Medtronic, Inc.
Address: 8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

Distribution pattern: International distribution of the country of UK. No US distribution.

Timeline

Recall initiated: 2025-04-29
Posted by FDA: 2025-06-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213459. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.