Abbott recalls TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN…

Recall date

May 22, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2541-2020

FDA classification

Class II

Brand / firm

Abbott

Sold / distributed

Worldwide distribution.

Why it was recalled

High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.