Recall Z-2541-2020— Abbott
Class II · Terminated
Class II FDA medical device recall by Abbott, initiated 2020-05-22, terminated 2021-02-11. FDA's recall record names no specific 510(k) clearance for this event. 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: High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter.
- Recalling firm
- Abbott
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-22
- Terminated
- 2021-02-11
- Firm location
- Plymouth, MN, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.