---
title: "Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 — FDA record Z-0238-2024 | Is It on Recall"
description: "Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds)."
url: https://isitonrecall.com/recall/fda-device-z-0238-2024-fogarty-thru-lumen-embolectomy-catheter-ref-12tlw805f35/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 — FDA record Z-0238-2024

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 7, 2023. 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**: Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
- **Reason**: Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
- **Classification**: Class II
- **Recalling firm**: Edwards Lifesciences, LLC
- **Quantity**: 185
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0238-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0238-2024%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 | UDI-DI: 00690103043532, Lot: 64936927 |

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

## Distribution

OUS: Singapore, Taiwan, Canada

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

## Dates in the source

- **Report date**: Nov 15, 2023
- **Recall initiation date**: Sep 7, 2023
- **Center classification date**: Nov 6, 2023

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-0238-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Edwards Lifesciences, LLC records](https://isitonrecall.com/brand/edwards-lifesciences-llc/)