Device 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 only. The catheter is designed to obtain electrograms in the atrial regions of the heart. LASSO NAV DUO LOOP eco Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.
Z-1242-2015
Product summary
- Event
- Event 70590
- Status
- Terminated
- Classification
- Class II
- Quantity
- 464 units
- Official record key
device-enforcement:Z-1242-2015
Official wording
Reason: Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.
Code information: All lots manufactured as of February 24, 2015 are affected.
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.