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Abbott recalls TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN
Recalled July 15, 2020 · FDA recall Z-2541-2020 · Abbott
Hazard
High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter · FDA Class II
Units
84104 devices
Sold at
Worldwide distribution.
Description
High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter
Product
TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart and, when connected to an RF generator, to deliver radiofrequency current to the catheter tip electrode for the purpose of ablation.
Manufacturer(s)
Abbott
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →