Medtronic Azure S SR MRI Recall for Temporary Feature Suspension
Medtronic is recalling 11,953 Azure S SR MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.
What this means for you
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 low-risk or voluntary precautionary recalls.
Plain-English summary
Medtronic Inc. is recalling 11,953 units of the Azure S SR MRI (Model Number W3SR01) worldwide. The recall is due to 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 S SR MRI, Model Number W3SR01
- Affected units
- 11,953
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.
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