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.
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 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.
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