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TactiFlex Sensor Enabled recallZ-0111-2026 · Abbott · initiated Sep 10, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abbott or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

FDA root cause category: Package design/selection

What the company is doing

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."

Recall details

Recall number
Z-0111-2026
Status
Open, Classified
Initiated by the company
Sep 10, 2025
Posted by the FDA
Oct 10, 2025
Recalling firm
Abbott
Quantity
85803 units
Product code
OAE
FDA submissions
P220013
Distribution
Worldwide

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (18k characters)

GTIN 05415067034571, Batch Numbers: 8707463, 8728375, 8848814, 8849428, 8856153, 8859777, 8930724, 8948407, 9085267, 9134878, 9139151, 9151701, 9154571, 9170156, 9172378, 9202684, 10005870, 10014420, 10014422, 10035838, 10060049, 10067495, 10074488, 10093061, 10095119, 10133240, 10143719, 10146336, 10150246, 10150248, 10158750, 10163256, 10168649, 10175479, 10191672, 10206135, 10219459, 10246287, 10250075, 10259721, 10266993, 10268128, 10278549, 10278947, 10278998, 10279023, 10279962, 10282364, 10284613, 10286135, 10299761, 10301720, 10301724, 10302971, 10310965, 10313193, 10321650, 10321684, 10330213, 10334312, 10337388, 10343800, 10346421, 10347095, 10350600, 10356054, 10356057, 10358260, 10358261, 10358263, 10358912, 10359408, 10359726, 10364782, 10368136, 10369950, 10373269, 10383386, 10392552, 10398359, 10399262, 10399266, 10401107, 10401352, 10405601, 10406221, 10413503, 10419427, 10420466, 10423182, 10424553, 10429934, 10433340, 10441923, 10442325, 10446371, 10466941, 10467483, 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10934160, 10934168, 10934169, 10934171, 10935608, 10936802, 10936804, 10936805, 10936811, 10938514, 10938632, 10938633, 10939030, 10939035, 10939180, 10939181, 10939182, 10939804, 10940144, 10940342, 10940343, 10940344, 10940345, 10940635, 10940649, 10940882, 10941309, 10941318, 10941321, 10941326, 10941566, 10950008, 10950024, 10950029, 10950031, 10950034, 10950037, 10951563, 10952564, 10952603, 10952604, 10952606, 10952608, 10954015, 10954508, 10954512, 10955717, 10956012, 10956522, 10956529, 10956530, 10957750, 10957999, 10958001, 10958136, 10958353, 10959352, 10959420, 10960185, 10962662, 10963003, 10963004, 10963432, 10963444, 10963446, 10963449, 10964882, 10964894, 10965222, 10965283, 10965293, 10965758, 10965762, 10967070, 10967383, 10967600, 10967639, 10968757, 10970143, 10972851, 10974662, 10976788, 10976802, 10978489, 10978490, 10978491, 10978492, 10978493, 10985515, 10987787, 11001366, 11001367, 11001368, 11008425, 11022729, 10917114, 10918927, 10922128, 10923747, 10932034, 10936492, 10936499, 10938539, 10941086, 10941569, 10952592, 10954107, 10954511, 10958355, 10959849, 10959850, 10967027, 10967028, 10967388, 10968503, 10968505, 10968738, 10969028, 10970142, 10970338, 10970349, 10970358, 10972424, 10972425, 10972426, 10972427, 10972849, 10972861, 10972865, 10974479, 10974480, 10974665, 10974681, 10976227, 10976255, 10976474, 10976778, 10976807, 10976987, 10978136, 10978678, 10978683, 10980067, 10980199, 10980898, 10983203, 10983441, 10983449, 10983892, 10985075, 10985378, 10985509, 10987475, 10988895, 10989409, 10990012, 10990076, 10990758, 10991009, 10993347, 10993686, 11037069, 11047469, 11047470, 11047471, 11065005, 11065006, 11065007, 11065008, 11065009, 11065010, 11065011, 11065012, 11071628, 10965759, 10972864, 10974062, 10976804, 10978680, 10978681, 10980198, 10980889, 10982507, 10983202, 10983426, 10986129, 10989279, 10989392, 10990760, 10990761, 10992107, 10993351, 10952598, 10965387, 10965405, 10966225, 10972964, 10974066, 10978510, 10980893, 10980895, 10985076, 10970654, 10970670, 10985073, 10987683.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

8 devices cleared under P220013 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97595).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page