Azure S DR MRI SureScan recall
Azure S DR MRI SureScan, Product number W3DR01
Why was Azure S DR MRI SureScan 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial numbers RNJ108800G, RNJ108808G, RNJ108810G UDI-DI 00763000956004 ***Updated 10/14/25*** Scope expanded to include implanted devices, serial numbers: RNJ108803G RNJ108804G RNJ108820G
- Product
- Azure S DR MRI SureScan, Product number W3DR01
- Recalling firm
- Medtronic, Inc.
- Quantity
- 6
- Distribution
- International distribution of the country of UK. No US distribution.
- Recall date
- June 18, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)