FDA Device recall Z-0110-2026

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

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, DD, (BiD Curve D-D), REF A-TFSE-DD 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-0110-2026
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, DD, (BiD Curve D-D), REF A-TFSE-DD; 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 05415067034557, Batch Numbers: 8843948, 8855039, 8906316, 8913730, 8921154, 8922146, 8933195, 8947323, 8949324, 8… 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

code_info

GTIN 05415067034557, Batch Numbers: 8843948, 8855039, 8906316, 8913730, 8921154, 8922146, 8933195, 8947323, 8949324, 8…

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

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-0110-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.