Medtronic Azure S DR MRI Recall for Temporary Feature Suspension
Medtronic is recalling 49,513 Azure S DR MRI devices because a rare communication issue may temporarily suspend certain device features.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source explicitly states the issue is unlikely to result in clinical impact and features are restored, fitting the criteria for a voluntary precautionary recall without reported injury.
Plain-English summary
Medtronic Inc. is recalling 49,513 Azure S DR MRI devices (Model Number W3DR01) distributed worldwide. The recall addresses a rare communication sequence that can occur during the first device interrogation with a SmartSync Device Manager.
This rare interaction may result in the temporary suspension of specific device features, including battery measurements, Capture Management, Atrial Lead Position Check, EffectivCRT algorithms, and AdaptivCRT. The issue also causes a temporary suspension of automatic threshold testing, output adjustments, and auto-optimization of CRT therapy.
The source text states that this issue is unlikely to result in clinical impact to the patient. The affected features are restored upon the next programmer device interrogation or the presence of a magnet.
The recalled product
- Product
- Azure S DR MRI, Model Number W3DR01
- Hazard
- Affected units
- 49,513
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
See all →- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- SevereAzure S DR MRI SureScan Pacemakers Recalled for Battery Failure Risk
FDA (Devices) · 2025-06-18
- ModerateMedtronic Recalls Implantable Pulse Generators Due to Longevity Estimation Error
FDA (Devices) · 2021-05-12
- HighMedtronic Recalls Specific CRT-P Pacemakers for Potential Malfunction
FDA (Devices) · 2013-07-03
- HighMedtronic MRI-Conditional Cardiac Devices Recalled for Software Feature Error
FDA (Devices) · 2017-01-18
- HighMedtronic Recalls MRI-Conditional Cardiac Resynchronization Therapy Devices
FDA (Devices) · 2017-05-31
- HighMedtronic Cobalt DR MRI SureScan Defibrillators Recalled for Potential Loss of Function
FDA (Devices) · 2021-02-03