Biosense Webster HIS Catheter Recall Due to Navigation System Compatibility Issue
Biosense Webster is recalling 503 Webster HIS Catheters because they are not recognized by the CARTO 3 navigation system.
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 text explicitly states no illnesses or injuries are reported, and the hazard is a functional compatibility issue rather than a direct physical injury risk, fitting the 'voluntary precautionary' or 'low-risk' criteria for a score of 2.
Plain-English summary
Biosense Webster, Inc. is recalling 503 units of the Webster HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology. The product is used for mapping cardiac structure, specifically for stimulation and recording. The recall is due to a compatibility issue where the catheter is not being recognized by the CARTO 3 navigation system.
The affected units were distributed nationwide in the United States. The recall covers specific lot numbers, including 17147443M, 17177237M, and 17196045M, among others. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare providers should stop using the affected catheters and contact Biosense Webster for further instructions. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413
- Manufacturer
- Biosense Webster, Inc.
- Affected units
- 503
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 (20)
- Lot No. 17147443M
- 17177237M
- 17196045M
- 17142745M
- 17176185M
- 17191133M
- 17177957M
- 17162927M
- 17163734M
- 17159129M
- 17157116M
- 17144954M
- 17192170M
- 17192723M
- 17173428M
- 17174967M
- 17174968M
- 17194186M
- 17194707M
- 17153400M
Distribution
Distributed nationwide across the United States.
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