# FDA recall Z-2085-2025

> **Edwards Lifesciences, LLC** · Class I · device recall initiated 2025-05-14.

## Product

Brand Name: FEM-FLEXII  Product Name: Femoral Arterial Cannula  Model/Catalog Number: FEMII018AS  Software Version: N/A  Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.  Component: No

## Reason for recall

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

## Distribution

Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA,  ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA,  FLORIDA, GEORGIA, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY,  LOUISIANA, MAINE, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI,  MISSOURI, MONTANA, NEBRASKA, NEVADA, NEW HAMPSHIRE, NEW JERSEY, NEW MEXICO,  NEW YORK, NORTH CAROLINA, NORTH DAKOTA, OHIO, OKLAHOMA, OREGON, PENNSYLVANIA, Puerto Rico, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA, TENNESSEE, TEXAS, UTAH, VIRGINIA, WASHINGTON, WEST VIRGINIA, WISCONSIN and the countries of Albania, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece,  Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta,  Netherlands, Northern Ireland, Norway, Pakistan, Panama, Poland, Portugal, Romania,  Singapore, Slovakia, South Africa, South Korea, Spa

## Key facts

- **Recall number:** Z-2085-2025
- **Recalling firm:** Edwards Lifesciences, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-14
- **Report date:** 2025-07-16

- **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-2085-2025

## Citation

> AI Analytics. FDA recall Z-2085-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2085-2025. Source: US FDA. Licensed CC0.

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