Device 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.
Z-2541-2020
Product summary
- Firm
- Abbott
- Event
- Event 85775
- Status
- Terminated
- Classification
- Class II
- Quantity
- 84104 devices
- Official record key
device-enforcement:Z-2541-2020
Official wording
Reason: High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter
Code information: All batch numbers with an expiration date of April 25, 2020
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter