Medtronic Serena CRT-P MRI Recall for Temporary Feature Suspension
Medtronic is recalling 17,750 Serena CRT-P 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 text explicitly states the issue is 'unlikely to result in clinical impact to the patient' and features are restored, fitting the criteria for a low-risk or voluntary precautionary recall.
Plain-English summary
Medtronic Inc. is recalling 17,750 units of the Serena CRT-P MRI device, including model numbers W1TR02, W1TR05, W4TR02, and W4TR05. The devices were distributed 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. The issue also leads to the 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. Patients and healthcare providers should be aware of this potential temporary suspension of features during the initial interrogation process.
The recalled product
- Product
- Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
- Hazard
- Affected units
- 17,750
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) W1TR02
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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