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Recall Observatory FDA recall evidence

Device product

20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.

Z-1617-2013

June 19, 2013

Class II

Product summary

Firm
Biosense Webster, Inc.
Event
Event 65506
Status
Terminated
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-1617-2013

Official wording

Reason: Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Catheter Eco by the CARTO 3 System.

Code information: Lot # 15832314L

Distribution pattern: Distributed in the states of MN, FL, and UT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Catheter Eco by the CARTO 3 System.