Medtronic Azure XT DR MRI Recall for Temporary Feature Suspension
Medtronic is recalling 266,252 Azure XT DR MRI devices worldwide due to a rare communication issue that 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 source explicitly states the issue is unlikely to result in clinical impact and features are restored, aligning with the rubric for low-risk or precautionary recalls where no injury is reported.
Plain-English summary
Medtronic Inc. is recalling 266,252 Azure XT DR MRI devices, model numbers W1DR01 and W2DR01, 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 leads to the temporary suspension of automatic threshold testing, output adjustments, and auto-optimization of CRT therapy.
According to the source, the 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 DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
- Hazard
- Affected units
- 266,252
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) W1DR01
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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