Recall Z-1344-2022 ยท OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Abbott
Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
| Date | Jul 7, 2022 (initiated Jun 9, 2022) |
| Status | Terminated |
| Reason | 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." |
| Root cause | 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 nee |
| Quantity | 191 devices |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.