FDA Device recall Z-0113-2026

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F

FDA Device
Class I
ongoing
Published 2025-10-22

On 2025-10-22 the FDA classified a Class I recall of TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F by Abbott, citing abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0113-2026
Classification	Class I
Status	ongoing
Initiated	2025-09-10
Published	2025-10-22
Last updated	2026-09-13 11:57 UTC
Company	Abbott
Distribution	n/a

Product

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

Reason

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

Identifiers

code_info	GTIN 05415067034670, Batch Numbers: 8894357, 8917490, 8984945, 10061309, 10061314, 10061316, 10061317, 10084510, 10084… GTIN 05415067034670, Batch Numbers: 8894357, 8917490, 8984945, 10061309, 10061314, 10061316, 10061317, 10084510, 10084518, 10089968, 10089971, 10099711, 10132013, 10132015, 10132017, 10217367, 10360478, 10360488, 10371567, 10371569, 10371577, 10399929, 10418884, 10418885, 10418895, 10429561, 10429563, 10479188, 10479190, 10482343, 10482351, 10482363, 10482378, 10513080, 10533833, 10533851, 10533854, 10566078, 10597230, 10646250, 10646251, 10646253, 10673213, 10673240, 10684728, 10684732, 10684739, 10684740, 10688513, 10692386, 10695444, 10705803, 10710366, 10713073, 10758992, 10792240, 10792924, 10803221, 10803222, 10812417, 10812431, 10830792, 10830798, 10835329, 10835331, 10861887, 10866457, 10868070, 10870874, 10872753, 10878395, 10878673, 10879391, 10879406, 10978688, 10978690.

code_info

GTIN 05415067034670, Batch Numbers: 8894357, 8917490, 8984945, 10061309, 10061314, 10061316, 10061317, 10084510, 10084…

GTIN 05415067034670, Batch Numbers: 8894357, 8917490, 8984945, 10061309, 10061314, 10061316, 10061317, 10084510, 10084518, 10089968, 10089971, 10099711, 10132013, 10132015, 10132017, 10217367, 10360478, 10360488, 10371567, 10371569, 10371577, 10399929, 10418884, 10418885, 10418895, 10429561, 10429563, 10479188, 10479190, 10482343, 10482351, 10482363, 10482378, 10513080, 10533833, 10533851, 10533854, 10566078, 10597230, 10646250, 10646251, 10646253, 10673213, 10673240, 10684728, 10684732, 10684739, 10684740, 10688513, 10692386, 10695444, 10705803, 10710366, 10713073, 10758992, 10792240, 10792924, 10803221, 10803222, 10812417, 10812431, 10830792, 10830798, 10835329, 10835331, 10861887, 10866457, 10868070, 10870874, 10872753, 10878395, 10878673, 10879391, 10879406, 10978688, 10978690.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0113-2026%22

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