Class 2 Device Recall Azure S DR MRI SureScan

• Date Initiated by Firm: April 29, 2025
• Date Posted: June 06, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1924-2025
• Recall Event ID: 96722
• PMA Number: P980035
• Product Classification: Pulse generator, permanent, implantable - Product Code NVZ
• Product: Azure S DR MRI SureScan, Product number W3DR01
• 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
• FEI Number: 2182208
• Recalling Firm/ Manufacturer: Medtronic, Inc.; 8200 Coral Sea St Ne; Mounds View MN 55112-4391
• For Additional Information Contact: Tracy McNulty; 763-505-6000
• Manufacturer 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.
• FDA Determined Cause: Process change control
• Action: 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.
• Quantity in Commerce: 6
• Distribution: International distribution of the country of UK. No US distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = NVZ