Medtronic Patient Connector Recall for Temporary Feature Suspension
Medtronic is recalling 1,025 Patient Connectors because a rare communication error may temporarily suspend device features. The issue is unlikely to cause clinical impact and features restore automatically.
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, fitting the criteria for a low-risk or voluntary precautionary recall (Score 2).
Plain-English summary
Medtronic Inc. is recalling 1,025 Patient Connector devices, Model Number 24967, 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 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 suspension affects automatic threshold testing, output adjustments, and the auto-optimization of CRT therapy. According to the source text, this issue is unlikely to result in clinical impact to the patient. The suspended features are restored upon the next programmer device interrogation or the presence of a magnet.
The recalled product
- Product
- Patient Connector, Model Number 24967
- Affected units
- 1,025
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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