# FDA recall Z-3077-2017

> **Edwards Lifesciences, LLC** · Class II · device recall initiated 2017-07-06.

## Product

Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806    Product Usage:  The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicated for the removal of emboli and thrombi from native arteries or synthetic grafts. The device are designed to facilitate clots too resistant to be removed by an elastomeric balloon. The device features a spiral-shaped, latex-covered stainless steel cable that assumes a corkscrew shape when retracted, greatly expanding the surface areas to entrap fibrous material. The device is 80 cm in length and is available in 4F-6F diameters.

## Reason for recall

The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.

## Distribution

Worldwide Distribution - US Nationwide GB, NL, DE, IT, FR, BE, ES, NO, CZ, BG, SE, AT, CH, PL, RU, FI

## Key facts

- **Recall number:** Z-3077-2017
- **Recalling firm:** Edwards Lifesciences, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-06
- **Report date:** 2017-09-06
- **Termination date:** 2018-10-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3077-2017

## Citation

> AI Analytics. FDA recall Z-3077-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-3077-2017. Source: US FDA. Licensed CC0.

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