Class 2 Device Recall TactiCath Sensor Enabled (SE), BiD, Curve DD

• Date Initiated by Firm: March 24, 2022
• Create Date: April 19, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0957-2022
• Recall Event ID: 89872
• PMA Number: P130026
• Product Classification: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Product Code OAE
• Product: Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
• Code Information: Lot numbers: 8181068, 8182131, 8198290, 8198350, 8200249, 8200300, 8201447, 8202313, 8203518, 8203835, 8203857, 8205760, and 8207547. UDI (01)05415067027634(17)230331(10)xxxxxxx (lot number).
• FEI Number: 3005334138
• 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: Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
• FDA Determined Cause: Process control
• Action: The recalling firm issued letters dated 3/24/2022 on 3/24/22 via hand-delivery. The letters explained the issue, the impact and associated risks, and the steps to reduce risk. The steps included not using any of the remaining inventory of the affected lots listed in Appendix A, complete and return the accompanying Acknowledgment Form, and return all remaining unused affected devices to the recalling firm. The consignee is informed their Abbott representative can assist in returning these devices and obtaining replacements. The notice is to be forwarded to anyone within their organization who may need to be notified and a copy of the notice should be kept along with the completed Acknowledgment Form for their records.
• Quantity in Commerce: 588 devices
• Distribution: Worldwide distribution - US Nationwide - there was government distribution but no military. The countries of Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Palestine, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Taiwan, and United Kingdom.
• 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