CLASS I ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report

TactiFlex Sensor Enabled Ablation Catheter, 8F, D, (UniD Curve D) recalled

Abbott is recalling TactiFlex Sensor Enabled Ablation Catheter, 8F, D, (UniD Curve D). The recall was initiated on 10 Sep 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesGTIN 05415067034656, Batch Numbers: 8894231, 8915981, 9029640, 9255006, 10001631, 10053399, 10103653, 10120408, 10151069, 10194386, 10194388, 10217380, 10389653, 10429584, 10440518, 10513213, 10513225, 10513232, 10513235, 10551326, 10562041, 10562047, 10562049, 10566077, 10597231, 10597242, 10597249, 10597260, 10613572, 10613581, 10613583, 10613585, 10632079, 10632621, 10632626, 10632634, 10646249, 10673011, 10675350, 10676858, 10677749, 10680007, 10757210, 10785266, 10798695, 10798697, 10816723, 10817847, 10817849, 10850906, 10850907, 10858157, 10858160, 10860077, 10871703, 10885761, 10885921, 10889919, 10892126, 10896652, 10898353, 10899933, 10900171, 10903297, 10903302, 10909596, 10910449, 10910454, 10913639, 10914972, 10917505, 10918937, 10922625, 10922639, 10928017, 10938688, 10939318, 10939319, 10939322, 10950790, 10954012, 10954308, 10954309, 10956216, 10956223, 10957148, 10960327, 10960343, 10961378, 10962731, 10956836, 10958929, 10984316, 10984788, 10985584, 10987173, 11076153, 10984516, 10985598, 10962737.

Quantity recalled407 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0109-2026
FDA event ID: 97595
Recalling firm: Abbott, Plymouth, MN
Classification: Class I
Status: Ongoing
Recall initiated: 10 Sep 2025
FDA classified: 10 Oct 2025
Reported: 22 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

10 Sep 2025	Recall initiated by company
10 Oct 2025	Classified by FDA	+30 days
22 Oct 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

Worldwide

Questions about this recall

Is TactiFlex Sensor Enabled Ablation Catheter, 8F, D, (UniD Curve D) recalled?

Yes. Abbott recalled TactiFlex Sensor Enabled Ablation Catheter, 8F, D, (UniD Curve D) on 10 Sep 2025. The recall is Class I and its status is Ongoing. Recall number Z-0109-2026.

Why was it recalled?

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

Which lots are affected?

GTIN 05415067034656, Batch Numbers: 8894231, 8915981, 9029640, 9255006, 10001631, 10053399, 10103653, 10120408, 10151069, 10194386, 10194388, 10217380, 10389653, 10429584, 10440518, 10513213, 10513225, 10513232, 10513235, 10551326, 10562041, 10562047, 10562049, 10566077, 10597231, 10597242, 10597249, 10597260, 10613572, 10613581, 10613583, 10613585, 10632079, 10632621, 10632626, 10632634, 10646249, 10673011, 10675350, 10676858, 10677749, 10680007, 10757210, 10785266, 10798695, 10798697, 10816723, 10817847, 10817849, 10850906, 10850907, 10858157, 10858160, 10860077, 10871703, 10885761, 10885921, 10889919, 10892126, 10896652, 10898353, 10899933, 10900171, 10903297, 10903302, 10909596, 10910449, 10910454, 10913639, 10914972, 10917505, 10918937, 10922625, 10922639, 10928017, 10938688, 10939318, 10939319, 10939322, 10950790, 10954012, 10954308, 10954309, 10956216, 10956223, 10957148, 10960327, 10960343, 10961378, 10962731, 10956836, 10958929, 10984316, 10984788, 10985584, 10987173, 11076153, 10984516, 10985598, 10962737.

Where was it sold?

Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Abbott

All 20

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, DF, (BiD Curve D-F) recalled	Abbott	Packaging Defects	MN
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, F, (UniD Curve F) recalled	Abbott	Packaging Defects	MN
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, DD, (BiD Curve D-D) recalled	Abbott	Packaging Defects	MN
22 Oct 2025Device	CLASS I	TactiFlex Sensor Enabled Ablation Catheter, 8F, FJ, (BiD Curve F-J) recalled	Abbott	Packaging Defects	MN
30 Apr 2025Device	CLASS II	Amplatzer TorqVue LP Catheter (Tvlpc) recalled by Abbott	Abbott	Lead & Heavy Metals	Nationwide

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