Recall Z-1023-2013— Biosense Webster, Inc.

Name: FDA recall Z-1023-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-05

Class II · Terminated

Class II FDA medical device recall by Biosense Webster, Inc., initiated 2013-03-05, terminated 2013-10-17. It names one FDA 510(k) clearance: K120550. Product: 20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.. Reason: Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the impacted 54 cable serial numbers within the field..

Recalling firm: Biosense Webster, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-03-05
Terminated: 2013-10-17
Firm location: Irwindale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K120550 — CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)Biosense Webster, Inc.·cleared 2012-05-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.

Reason for recall

Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the impacted 54 cable serial numbers within the field.

Data sourced from openFDA. This site is unofficial and independent of the FDA.