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.
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 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.
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