Biosense Webster Recalls LASSO NAV Duo Loop eco Catheters
Biosense Webster is recalling LASSO NAV Duo Loop eco Catheters due to reports of difficulty retracting and damage to the spine cover.
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 reported mechanical defects (difficulty retracting and spine cover damage) that pose a risk of harm during cardiac procedures, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Biosense Webster, Inc. is recalling LASSO NAV Duo Loop eco Catheters, Catalog Nos. D-1354-01 through D-1354-06. The recall involves 464 units that were distributed nationwide. All lots manufactured as of February 24, 2015, are affected.
The recall is being conducted because of reports of difficulty retracting and damage to the spine cover of the catheters. These devices are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, specifically for recording or stimulation in the atrial regions. They provide location information when used with compatible CARTO 3 EP Navigation Systems.
Healthcare providers and facilities that have received these devices should stop using them and contact Biosense Webster for further instructions on the recall process.
The recalled product
- Product
- LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation…
- Manufacturer
- Biosense Webster, Inc.
- Hazard
- Affected units
- 464
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 (2)
- All lots manufactured as of February 24
- 2015 are affected.
Distribution
Distributed nationwide across the United States.
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