Lower risk Medical device recall · FDA · Published May 14, 2025

Edwards Optisite Arterial Cannula Recall: 3-4mm Wire Exposed Risk

Edwards Lifesciences recalls Optisite Arterial Cannula model OPTI16 due to 3-4mm wire exposed/protruding, which may cause injury during medical procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2080-2025Medical device Edwards Lifesciences ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmEdwards Lifesciences, LLC1 Edwards Way · Irvine, CA 92614-5688

✎ GovInfoNow plain-language explainer

Edwards Lifesciences is recalling Optisite Arterial Cannula model OPTI16 because a 3-4mm section of wire is exposed or protruding from the cannula body. This could lead to injury during medical procedures if the cannula is used improperly. Read more at govinfonow.com/recall/52271-edwards-optisite-arterial-cannula-recall-3-4mm-wire-exposed-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/52271-edwards-optisite-arterial-cannula-recall-3-4mm-wire-exposed-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2080-2025

Cite this page

“Edwards Optisite Arterial Cannula Recall: 3-4mm Wire Exposed Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52271-edwards-optisite-arterial-cannula-recall-3-4mm-wire-exposed-risk. Based on FDA recall #Z-2080-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2080-2025%22&limit=1).

The FDA announced on May 14, 2025, that Edwards Lifesciences, LLC is recalling Optisite Arterial Cannulas due to exposed wire hazards. The agency issued recall number Z-2080-2025 for the Class I voluntary recall affecting worldwide distribution.

How to tell if you have it

Brand: Edwards Lifesciences
Product Name: Optisite Arterial Cannula
Model/Catalog Number: OPTI16
Lot Code: All lots up to BSLC9149
Serial Numbers: 130467, 130471, 130602, 130765, 130816, 130822, 130852, 130949, 131039, 131041, 131044, 131237, 131312, 131428, 131509, 131826, 131887, 131908, 132338, 132436, 132503, 132831, BSLC0040, BSLC0165, BSLC0320, BSLC1309, BSLC1468, BSLC1557, BSLC1682, BSLC1688, BSLC1825, BSLC1830, BSLC5302, BSLC5899, BSLC6166, BSLC7142, BSLC7513, BSLC8176, BSLC8659
Units affected: 27,022

The hazard

The recall is due to complaints received regarding the 3mm to 4mm section wire being exposed or protruding from the outside of the cannula body. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show Edwards Lifesciences, LLC has 25 other recalls on file since July 6, 2017. Recent Edwards recalls include a March 27, 2026 labeling update for the EVOQUE Tricuspid Delivery System and an Oct. 4, 2023 recall of FloTrac Sensors for potential flushing difficulties. Other recent recalls of similar products include Medtronic EOPA Arterial Cannula recalls dated June 24, 2026.

How to tell if you have this one

Check for the model number OPTI16 on the cannula. The affected units have serial numbers listed in the recall notice, including 130467, 130471, and other specific serial numbers provided in the record.

Brand
Edwards Lifesciences
Category
Medical device

FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
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, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates (UAE), United Kingdom.

Recall number	Product, codes & lots	Quantity
Z-2080-2025	Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No.; Lot Code: Model No:OPTI16; UDI: 00690103180558; All lots up to BSLC9149 Serial Numbers: 130467 130471 130602 130765 130816 130822 130852 130949 131039 131041 131044 131237 131312 131428 131509 131826 131887 131908 132338 132436 132503 132831 BSLC0040 BSLC0165 BSLC0165 BSLC0320 BSLC1309 BSLC1309 BSLC1468 BSLC1468 BSLC1557 BSLC1682 BSLC1688 BSLC1825 BSLC1830 BSLC5302 BSLC5899 BSLC6166 BSLC7142 BSLC7142 BSLC7513 BSLC8176 BSLC8659 BSLC9149	27022
Z-2081-2025	Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No; Lot Code: Model No: OPTI18; UDI: 00690103180565; All lots up to: BSLC9155 Serial Numbers: 130451 130466 130472 130593 130709 130764 130818 130821 130847 130948 130952 131038 131043 131047 131182 131193 131231 131236 131289 131311 131317 131433 131435 131513 131516 131553 131554 131606 131623 131625 131628 131682 131737 131909 131929 131966 132175 132201 132366 132395 132416 132430 132435 132505 132832 132958 132959 BSLC0110 BSLC0166 BSLC0661 BSLC0661 BSLC0826 BSLC0826 BSLC0826 BSLC0826 BSLC0855 BSLC0855 BSLC0887 BSLC0887 BSLC0979 BSLC1114 BSLC1114 BSLC1211 BSLC1308 BSLC1469 BSLC1656 BSLC1660 BSLC1815 BSLC3221 BSLC4153 BSLC4400 BSLC4461 BSLC4513 BSLC5027 BSLC5027 BSLC5320 BSLC5367 BSLC5765 BSLC6421 BSLC6467 BSLC7335 BSLC7514 BSLC7515 BSLC8175 BSLC8385 BSLC8535 BSLC8657 BSLC9100 BSLC9104 BSLC9105 BSLC9152 BSLC9155	13240
Z-2082-2025	Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No; Lot Code: Model No: FEMII016A; UDI: 00690103031232; All lots up to: BSLC8179 Serial Numbers: 130544 130757 131105 131313 131511 131535 131888 131925 132504 BSLC0184 BSLC0386 BSLC0596 BSLC1311 BSLC3741 BSLC4162 BSLC5040 BSLC6487 BSLC8179	6801
Z-2083-2025	Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No; Lot Code: Model No; FEMII016AS; UDI: 0060913168341; All lots up to: BSLC1689 Serial Numbers: FEMII016AS FEMII016AS FEMII016AS	847
Z-2084-2025	Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No; Lot Code: Model No: FEMII018A; UDI: 0069013031256; All lots up to: BSLC9148 Serial Numbers: 130468 130599 130704 130848 130953 131048 131286 131430 131626 131774 131775 132004 132005 132510 BSLC0025 BSLC0121 BSLC0422 BSLC1115 BSLC1470 BSLC4161 BSLC4472 BSLC5041 BSLC5293 BSLC5842 BSLC6163 BSLC6164 BSLC7336 BSLC7794 BSLC8660 BSLC9148	13240
Z-2085-2025	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; Lot Code: Model No: FEMII018AS; UDI: 00690103168358; All lots up to: BSLC9064 Serial Numbers: 131776 BSLC4190 BSLC9064	558

Based on the official FDA remedy

What to do — step by step

Check Product Serial Number
Look for the serial numbers listed in the recall notice, such as 130467, 130471, and others.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 47 states.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: 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.

Recall timeline

FDA published this recall 2 months after the firm started it.

May 14, 2025Firm started the recall
Jul 10, 2025FDA classified it Class I
Jul 16, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this product safe to use?

The recall indicates a potential risk, but the product is not unsafe for general use. Healthcare professionals should check the serial number to determine if it is affected.

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Link to this recall

<a href="https://govinfonow.com/recall/52271-edwards-optisite-arterial-cannula-recall-3-4mm-wire-exposed-risk">Edwards Optisite Arterial Cannula Recall: 3-4mm Wire Exposed Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2080-2025 (May 14, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2080-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.