Z-2541-2020 Class II Terminated
FDA device recall Z-2541-2020 was initiated by Abbott on May 22, 2020 and is designated Class II. Reason for recall: High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter The recall status is terminated (terminated February 11, 2021). Affected quantity: 84104 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2020
- Initiation Date
- May 22, 2020
- Termination Date
- February 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 84104 devices
Product Description
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 Pattern
Worldwide distribution.
Code Information
All batch numbers with an expiration date of April 25, 2020