CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report

Azure S DR MRI SureScan, Product number W3DR01 recalled by Medtronic

Medtronic is recalling Azure S DR MRI SureScan, Product number W3DR01. The recall was initiated on 29 Apr 2025 and the FDA has classified it as Class II.

Check your package

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

Quantity recalled6

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1924-2025
FDA event ID: 96722
Recalling firm: Medtronic, Mounds View, MN
Classification: Class II
Status: Ongoing
Recall initiated: 29 Apr 2025
FDA classified: 6 Jun 2025
Reported: 18 Jun 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

29 Apr 2025	Recall initiated by company
6 Jun 2025	Classified by FDA	+38 days
18 Jun 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Azure S DR MRI SureScan, Product number W3DR01

Where it was distributed

International distribution of the country of UK. No US distribution.

Questions about this recall

Why was it recalled?

Which lots 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

Where was it sold?

International distribution of the country of UK. No US distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Medtronic

All 148

Reported	Class	Recall	Company	Reason	Where
6 May 2026Device	CLASS II	Sphere-9 Catheter recalled by Medtronic	Medtronic	Other	MN
21 Jan 2026Device	CLASS II	Abre Venous Self-Expanding Stent System recalled by Medtronic	Medtronic	Other	Nationwide
30 Jul 2025Device	CLASS II	CareLink SmartSync Device Manager recalled by Medtronic	Medtronic	Device Malfunction	Nationwide
30 Jul 2025Device	CLASS II	CareLink SmartSync Patient Connector recalled by Medtronic	Medtronic	Device Malfunction	Nationwide
23 Jul 2025Device	CLASS II	Medtronic SmartLink software loaded on CareLink SmartSync Device recalled	Medtronic	Device Malfunction	MN

Other Imaging Equipment recalls

All 2,347

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide