Biosense Webster Recalls 20-Pole LASSO Nav Catheter Eco Due to Calibration Error
Biosense Webster is recalling 10 units of the 20-Pole LASSO Nav Catheter Eco because incorrect calibration causes the CARTO 3 System to display them as 10-Pole devices.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect (incorrect calibration) that could lead to improper use or mapping, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Biosense Webster, Inc. is recalling 10 units of the 20-Pole LASSO Nav Catheter Eco (Catalog # D-1349-02S, Lot # 15832314L). The device is designed to facilitate electrophysiological mapping of the atria of the heart.
The recall is being conducted because the catheters have been incorrectly calibrated. This error causes the devices to be recognized and displayed as a 10-Pole LASSO Nav Catheter Eco by the CARTO 3 System.
The affected units were distributed in the states of Minnesota, Florida, and Utah. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
- Manufacturer
- Biosense Webster, Inc.
- Affected units
- 10
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)
- Lot # 15832314L
Distribution
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