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U.S. Department of Health and Human Services

Class 2 Device Recall TactiCath Quartz Contact Force Ablation Catheter

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  Class 2 Device Recall TactiCath Quartz Contact Force Ablation Catheter see related information
Date Initiated by Firm May 22, 2020
Create Date July 10, 2020
Recall Status1 Terminated 3 on February 11, 2021
Recall Number Z-2541-2020
Recall Event ID 85775
PMA Number P130026 
Product Classification Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Product Code OAE
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.
Code Information All batch numbers with an expiration date of April 25, 2020
Recalling Firm/
Manufacturer		 Abbott
5050 Nathan Ln N
Plymouth MN 55442-3209
For Additional Information Contact Mr. Frank Gomez
818-493-2434
Manufacturer 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 2		 Process control
Action 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.
Quantity in Commerce 84104 devices
Distribution Worldwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = OAE and Original Applicant = St. Jude Medical
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