FDA recall Z-2541-2020

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.

Reason for recall

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

Distribution

Worldwide distribution.

Key facts

Status

Terminated

Initiation date

2020-05-22

Report date

2020-07-15

Termination date

2021-02-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2541-2020