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.
FDA Recall Z-1023-2013 · Posted 2013-03-28
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Recalling FirmBiosense Webster, Inc.
Recall StatusTerminated
Product CodeDQK
Date Initiated2013-03-05
Date Terminated2013-10-17
Product Quantity54 units
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.
Firm Action
Biosense Webster sent an Urgent Field Notice Medical Device Letter dated March 5, 2013 to all affected customers. The letter identified the affected product, problem and the actions to be taken. Customers with questions are instructed to contact Biosense Webster sales representatives or call (866) 473-7823, Mon-Friday from 7amto 8pm EST.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution - USA (Nationwide) including the states of: DE, NL, CH, FR, GB, DK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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