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Azure S DR MRI SureScan, Product number W3DR01 recallZ-1924-2025 · Medtronic, Inc. · initiated Apr 29, 2025

Class II Open, Classified All recalls posted in June 2025

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Process change control

What the company is doing

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.

Recall details

Recall number
Z-1924-2025
Recall class
Class II
Status
Open, Classified
Initiated by the company
Apr 29, 2025
Posted by the FDA
Jun 6, 2025
Recalling firm
Medtronic, Inc.
Quantity
6
Product code
NVZ
FDA submissions
P980035
Distribution
International distribution of the country of UK. No US distribution.

Product description

Azure S DR MRI SureScan, Product number W3DR01

Code information (models, lots, serial numbers)

Serial numbers RNJ108800G, RNJ108808G, RNJ108810G UDI-DI 00763000956004 ***Updated 10/14/25*** Scope expanded to include implanted devices, serial numbers: RNJ108803G RNJ108804G RNJ108820G

Other devices under the same FDA submission

71 devices cleared under P980035 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page