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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott

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  Class 2 Device Recall Abbott see related information
Date Initiated by Firm June 09, 2022
Date Posted July 07, 2022
Recall Status1 Open3, Classified
Recall Number Z-1344-2022
Recall Event ID 90414
PMA Number P130026S036 
Product Classification Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Product Code OAE
Product Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
Code Information UDI 01)05415067027665(17)230831(10)xxxxxxx, Batch Numbers 8409416, 8409675, 8410811
Recalling Firm/
Manufacturer		 Abbott
5050 Nathan Ln N
Plymouth MN 55442-3209
For Additional Information Contact Shelley Lange
651-756-4091
Manufacturer Reason
for Recall		 When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter."
FDA Determined
Cause 2		 Device Design
Action The firm notified its consignees by hand delivered Medical Device Recall letter on 06/09/2022. The letter explained the problem and provided the following instructions: "Next Steps To help reduce risk, we recommend: " Do not use any remaining inventory from the affected lots listed in Appendix A. " Complete and return the accompanying Acknowledgement Form to Abbott. " Return all remaining unused affected devices to Abbott. Your Abbott representative can assist you in returning these devices and obtaining replacements. Please forward this notice to anyone within your organization who may need to be notified and maintain a record of this notice along with a copy of the completed Acknowledgement Form for your records."
Quantity in Commerce 191 devices
Distribution US Nationwide 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = OAE and Original Applicant = St. Jude Medical
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