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

Recall number

Z-0111-2026

Recalling firm

Abbott

Product

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

Status

Open, Classified

Initiated

2025-09-10

Posted

2025-10-10

Terminated

not on file

Reason

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

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

85803 units

Distribution

Worldwide

Lot, serial or model codes

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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.

510(k) numbers

not on file

PMA numbers

["P220013"]

Product code

OAE

Firm FEI

3005334138

Firm city

Plymouth

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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