Class I U.S. Food and Drug Administration

Abbott TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D recall: Abbott has become aware of a limited number of tip detachment events during

Recall published 1+ years ago

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

The hazard: Fall or tip-over hazard

The recall is about structural failure — a frame, joint, leg or lock that does not hold under ordinary use.

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

Why it matters: The product can tip, collapse or give way under normal use. Furniture tip-overs in particular kill and injure young children, usually when a child climbs on an open drawer.

Symptoms and when to call a doctor

After a fall or a tip-over involving a child, watch for a headache that gets worse, repeated vomiting, drowsiness that is hard to rouse, confusion, unequal pupils, clear fluid from the nose or ear, or a seizure, and call 911 if any of these appear. Any fall onto the head in a baby under one, or any loss of consciousness at any age, needs to be assessed the same day.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0109-2026
Published
October 22, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Abbott
Product type
Medical devices
Units affected
407 units
Made in
United States
Lot / code info
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.
UPC codes
05415067034656

Products covered by this recall

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

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 05415067034656

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 8894231
  • 8915981
  • 9029640
  • 9255006
  • 10001631
  • 10053399
  • 10103653
  • 10120

Model or item number

On the rating label, the box or the instruction sheet.

  • A-TFSE-D

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Fall

Abbott — The recall is about structural failure — a frame, joint, leg or lock that does not hold under ordinary use.

  1. Stop using the product and, if it is furniture, move it out of a child’s room until the remedy is done.
  2. Inspect similar units from the same range, since a weak joint or fastener usually affects a whole production run.
  3. Follow the remedy on this page; many of these recalls supply a free anchoring kit as well as a refund.
  4. Anchor tall furniture to the wall with a tip-over restraint — this is worth doing for every chest and bookcase in the house, not just this one.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • A replacement is usually the current model, not the recalled one. Confirm the replacement is not itself under recall.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.

Company contact: Abbott — 5050 Nathan Ln N, Plymouth, MN, 55442-3209

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Abbott medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 05415067034656; lot code 8894231, 8915981, 9029640; model number A-TFSE-D. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the product and, if it is furniture, move it out of a child’s room until the remedy is done.

Can I get my money back?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

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