Recall Z-0110-2026
Abbott · initiated September 10, 2025
Class I – dangerous or defective products that could cause serious health problems or death
Product
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
Codes / lots: GTIN 05415067034557, Batch Numbers: 8843948, 8855039, 8906316, 8913730, 8921154, 8922146, 8933195, 8947323, 8949324, 8958968, 8959452, 8960986, 8961409, 8963254, 8965484, 8965486, 8991236, 8993365, 9001917, 9003044, 9003047, 9012222, 9013428, 9015293, 9038354, 9039239, 9065946, 9066884, 9071294, 9119487, 9138236, 9147733, 9148411, 9156153, 9158891, 10162247, 10173398, 10205310, 10207502, 10218030, 10228449, 10228450, 10230429, 10232940, 10235434, 10235436, 10240235, 10242138, 10242992, 10242995, 10280672, 10288053, 10288057, 10289553, 10289668, 10289709, 10289759, 10297899, 10334695, 10334845, 10338853, 10338856, 10343551, 10360411, 10375524, 10382430, 10384530, 10384531, 10395601, 10395605, 10449220, 10451314, 10451768, 10451769, 10458698, 10465076, 10465083, 10465086, 10466761, 10469707, 10509213, 10565373, 10565827, 10566663, 10599493, 10600697, 10601488, 10610624, 10615028, 10628998, 10629000, 10638074, 10638488, 10639808, 10641833, 10645657, 10651462, 10651463, 10652440, 10657253, 10696081, 10696560, 10696907, 10705798, 10737121, 10737122, 10737249, 10737251, 10741862, 10742337, 10742342, 10744906, 10748214, 10748215, 10748680, 10749783, 10749788, 10749790, 10763049…
Reason for recall
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
FDA-determined cause: Package design/selection
Action taken
Abbott issued a Medical Device Advisory to its consignees on 09/10/2025 by letter delivered via Federal Express. The notice explained the issue, impact and associated risk to the patient and requested the following: "Action Requested/Recommendations/Next Steps . Continue following the product IFU by inspecting the packaging and catheter for damage and/or kinking prior to use. . Review the guidance in Appendix A information on proper removal technique of the TactiFlex" Ablation Catheter, Sensor Enabled" from the packaging tray, ensuring to inspect the electrodes and catheter tip carefully for integrity and overall condition prior to use. . Abbott has made changes to the packaging tray design to help mitigate tip damage during catheter removal from the packaging. The deployment of the new packaging has begun. Please complete the provided Acknowledgement Form with the assistance of your Abbott representative. This form ensures you are aware of the advisory notice and have been given an opportunity to ask questions. Please forward this notice to anyone in your organization who may need to be notified and maintain this notice for your records to ensure effectiveness of this communication. Should you have questions about this issue, please contact your local Abbott representative or Abbott Support at 1-855-478-5833 (U.S), 8:30 a.m. - 5:30 p.m. Central Standard Time, Monday thru Friday."
Details
- Recall number
- Z-0110-2026
- Initiated
- September 10, 2025
- Posted by FDA
- October 10, 2025
- Product code
- OAE – Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Quantity
- 3404 units
- Distribution
- Worldwide
- Recalling firm
- Abbott, Plymouth, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0109-2026 Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D…Abbott has become aware of a limited number of tip detachment events during catheter removal from the… | 09/10/2025Open, Classified |
| Z-0111-2026 Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF…Abbott has become aware of a limited number of tip detachment events during catheter removal from the… | 09/10/2025Open, Classified |
| Z-0112-2026 Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF…Abbott has become aware of a limited number of tip detachment events during catheter removal from the… | 09/10/2025Open, Classified |
| Z-0113-2026 Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F…Abbott has become aware of a limited number of tip detachment events during catheter removal from the… | 09/10/2025Open, Classified |