Biosense Webster Recalls ThermoCool SmartTouch Navigation Catheters for Labeling
Biosense Webster is recalling ThermoCool SmartTouch Navigation Catheters to provide additional labeling for safe and effective use.
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 and involves a labeling update to ensure safe and effective use, which aligns with the rubric for moderate severity involving labeling issues without reported injuries.
Plain-English summary
Biosense Webster, Inc. is recalling ThermoCool SmartTouch Navigation Catheters, including catalog numbers D132701 through D133603. The recall involves 173,329 units total, with 21,812 units distributed in the United States. The products were distributed nationwide.
The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter. The source text does not specify the exact nature of the labeling change or any specific safety hazard associated with the current labeling.
Healthcare providers and facilities should contact Biosense Webster for instructions on how to obtain the updated labeling and manage the affected units.
The recalled product
- Product
- ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
- Manufacturer
- Biosense Webster, Inc.
- Category
- Medical Device — Catheter
- Hazard
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 (8)
- Catalog No. D132701
- D132702
- D132703
- D132704
- D132705
- D133601
- D133602
- D133603 All Lots manufactured from launch (Dec 2010)
Distribution
Distributed nationwide across the United States.
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