Summary
The FDA issued a Class II for Azure S DR MRI SureScan, Product number W3DR01 by Medtronic, Inc.. Reason: Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential pat.
Details
Source
Device Recall
External ID
Z-1924-2025
Action Date
2025-06-18
Status
Ongoing
Category
device
Product Description
Azure S DR MRI SureScan, Product number W3DR01
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
Quantity Affected: 6
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.
Distribution
International distribution of the country of UK. No US distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-29
Company
Mounds View, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic, Inc. has 83 FDA actions in our database, including 46 recalls and 37 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic, Inc. have FDA actions?
Medtronic, Inc. has 83 FDA actions in our database, including 46 recalls and 37 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1924-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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