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Terminated

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.

FDA Recall Z-2541-2020 · Posted None

Recalling FirmAbbott
Recall StatusTerminated
Product CodeOAE
Date Initiated2020-05-22
Date Terminated2021-02-11
Product Quantity84104 devices

Reason for Recall

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

Firm Action

The firm began notifying their consignees by letter on 05/22/2020. The notification reported the high rate of reported complaints for loss of contact force information while using the product, the risk to patient, and recommendations to avoid contact force failures.

Root Cause

Process control

Distribution Pattern

Worldwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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