FDA Device recall Z-0111-2026

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

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, DF, (BiD Curve D-F), REF A-TFSE-DF 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-0111-2026
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, DF, (BiD Curve D-F), REF A-TFSE-DF; 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 05415067034571, Batch Numbers: 8707463, 8728375, 8848814, 8849428, 8856153, 8859777, 8930724, 8948407, 9085267, 9… 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,

code_info

GTIN 05415067034571, Batch Numbers: 8707463, 8728375, 8848814, 8849428, 8856153, 8859777, 8930724, 8948407, 9085267, 9…

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,

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-0111-2026%22

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