Medtronic Azure XT SR MRI Recall for Temporary Feature Suspension
Medtronic is recalling 31,736 Azure XT SR MRI devices due to a rare communication issue that temporarily suspends 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 source explicitly states the issue is unlikely to result in clinical impact and features are restored, aligning with the rubric for voluntary precautionary recalls or low-risk issues.
Plain-English summary
Medtronic Inc. is recalling 31,736 Azure XT SR MRI devices, model numbers W1SR01 and W2SR01, 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. Additionally, automatic threshold testing, output adjustments, and auto-optimization of CRT therapy may be temporarily suspended.
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 XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
- Affected units
- 31,736
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- a) W1SR01
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 →- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- SevereAzure S DR MRI SureScan Pacemakers Recalled for Battery Failure Risk
FDA (Devices) · 2025-06-18
- HighMedtronic MRI-Conditional Cardiac Devices Recalled for Software Feature Error
FDA (Devices) · 2017-01-18
- ModerateMedtronic Recalls Implantable Pulse Generators Due to Longevity Estimation Error
FDA (Devices) · 2021-05-12
- HighMedtronic Recalls CRT-P Quad Models Due to Software Longevity Error
FDA (Devices) · 2021-05-12
- HighMedtronic Percepta CRT-P MRI SureScan Devices Recalled for Potential Reset
FDA (Devices) · 2018-07-18
- HighMedtronic Recalls MRI-Conditional Cardiac Resynchronization Therapy Devices
FDA (Devices) · 2017-05-31