Z-1924-2025Class II

Azure S DR MRI SureScan, Product number W3DR01

Name: Z-1924-2025 Azure S DR MRI SureScan, Product number W3DR01
Creator: Medtronic, Inc.
Published: 2025-04-29
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2025-04-29 / Open, Classified

FDA source

Medtronic, Inc. began a recall of Azure S DR MRI SureScan, Product number W3DR01 on 2025-04-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1924-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-29
Posted: 2025-06-06
Recalling firm: Medtronic, Inc.
Product: Azure S DR MRI SureScan, Product number W3DR01
Product code: NVZ Pulse Generator, Permanent, Implantable
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 root 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.
Product codes and lots: Serial numbers RNJ108800G, RNJ108808G, RNJ108810G UDI-DI 00763000956004 ***Updated 10/14/25*** Scope expanded to include implanted devices, serial numbers: RNJ108803G RNJ108804G RNJ108820G

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1924-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1924-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-06

Product code NVZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)