Recall Z-0956-2022 ยท OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Abbott
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
| Date | Mar 24, 2022 |
| Status | Terminated |
| Reason | Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device. |
| Root 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 w |
| Quantity | 2,134 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.