Z-0112-2026Class I

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter

Name: Z-0112-2026 TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Creator: Abbott
Published: 2025-09-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2025-09-10 / Open, Classified / root cause: packaging

FDA source

Abbott began a recall of TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter on 2025-09-10. FDA classified it as Class I and gives the reason as "Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0112-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-09-10
Posted: 2025-10-10
Recalling firm: Abbott Medical
Product: TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Product code: OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Reason for recall: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: 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."
Quantity in commerce: 11810 units
Distribution: Worldwide
Product codes and lots: GTIN 05415067034618, Batch Numbers: 10093213, 10093588, 10095366, 10096269, 10118676, 10131389, 10151333, 10180969, 10286877, 10315661, 10317649, 10329929, 10332297, 10344177, 10350400, 10360030, 10374171, 10375844, 10418954, 10431765, 10433617, 10450462, 10492093, 10494298, 10537000, 10537747, 10538321, 10557710, 10557878, 10558450, 10559655, 10569703, 10570507, 10571902, 10571907, 10574230, 10575746, 10575752, 10577567, 10578953, 10579724, 10580699, 10581612, 10581681, 10583203, 10583793, 10587033, 10587043, 10587653, 10589068, 10589921, 10591178, 10591238, 10592227, 10606628, 10606720, 10608438, 10608708, 10611469, 10611683, 10612686, 10614973, 10616329, 10618038, 10619154, 10621180, 10622172, 10622962, 10622967, 10625101, 10630682, 10630687, 10632744, 10633145, 10634830, 10636059, 10637023, 10639373, 10639374, 10639376, 10639377, 10641739, 10641741, 10642345, 10643887, 10644681, 10645838, 10646429, 10648576, 10662844, 10665077, 10666137, 10667210, 10667217, 10668065, 10668185, 10670353, 10670360, 10671604, 10671663, 10672934, 10674544, 10675329, 10675541, 10677719, 10677722, 10678784, 10680052, 10680962, 10684449, 10691502, 10691504, 10691507, 10692805, 10696082, 10696083, 10696084, 10705825, 10708749, 10708800, 10709735, 10711022, 10711803, 10712639, 10712641, 10714607, 10714611, 10715850, 10717049, 10717050, 10719520, 10721238, 10721239, 10725441, 10725442, 10747196, 10749817, 10749820, 10749823, 10751484, 10762186, 10762464, 10764517, 10764523, 10765657, 10766897, 10767820, 10769643, 10770889, 10772623, 10772625, 10773775, 10773811, 10776251, 10777548, 10778157, 10779451, 10808389, 10808390, 10808393, 10811066, 10811067, 10811262, 10821034, 10827717, 10829276, 10829990, 10830744, 10832015, 10832019, 10832727, 10834411, 10834412, 10835187, 10836468, 10836482, 10836911, 10837558, 10837559, 10839959, 10839960, 10841679, 10841690, 10842962, 10845198, 10845199, 10846600, 10847688, 10847695, 10850757, 10850761, 10856004, 10856065, 10858260, 10867490, 10867495, 10868706, 10873737, 10873924, 10875772, 10875773, 10877194, 10897765, 10899500, 10899504, 10902557, 10902569, 10905178, 10905907, 10906368, 10907259, 10909995, 10910050, 10911332, 10911333, 10913977, 10915227, 10915230, 10920111, 10922315, 10922528, 10924643, 10924802, 10927218, 10954504, 10954507, 10955716, 10956520, 10956521, 10958150, 10959364, 10959373, 10960184, 10962699, 10965714, 10970014, 10970054, 10985513, 10989401, 10990017, 10990759, 10992074, 10992078, 10987781.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0112-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0109-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-10
Z-0110-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-10
Z-0111-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-10
Z-0112-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-10
Z-0113-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-10

Product code OAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)