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.
- Company
- Abbott
- Recall Initiated
- May 22, 2020
- Terminated
- February 11, 2021
- Recall Number
- Z-2541-2020
- Quantity
- 84104 devices
- Firm Location
- Plymouth, MN
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.
Lot / Code Info
All batch numbers with an expiration date of April 25, 2020
Root Cause
Process control
Action Taken
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.
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