---
title: "TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), RE... — FDA record Z-0109-2026 | Is It on Recall"
description: "Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging."
url: https://isitonrecall.com/recall/fda-device-z-0109-2026-tactiflex-sensor-enabled-ablation-catheter-8f-115-cm-d-unid-curve-d-ref-a-tfse-d-cardiac-catheter/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter — FDA record Z-0109-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 10, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
- **Reason**: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- **Classification**: Class I
- **Recalling firm**: Abbott
- **Quantity**: 407 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0109-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0109-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Worldwide

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Oct 22, 2025
- **Recall initiation date**: Sep 10, 2025
- **Center classification date**: Oct 10, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0109-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Abbott records](https://isitonrecall.com/brand/abbott/)