Recall Z-1344-2022
Abbott · initiated June 9, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
Codes / lots: UDI 01)05415067027665(17)230831(10)xxxxxxx, Batch Numbers 8409416, 8409675, 8410811
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: Device Design
Action taken
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."
Details
- Recall number
- Z-1344-2022
- Initiated
- June 9, 2022
- Posted by FDA
- July 7, 2022
- Product code
- OAE – Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Quantity
- 191 devices
- Distribution
- US Nationwide distribution.
- Recalling firm
- Abbott, Plymouth, MN