Recall Z-2541-2020
Abbott · initiated May 22, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: All batch numbers with an expiration date of April 25, 2020
Reason for recall
High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter
FDA-determined 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.
Details
- Recall number
- Z-2541-2020
- Initiated
- May 22, 2020
- Terminated
- February 11, 2021
- Product code
- OAE – Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Quantity
- 84104 devices
- Distribution
- Worldwide distribution.
- Recalling firm
- Abbott, Plymouth, MN