Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software V
Summary
The FDA issued a Class I for Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula by Edwards Lifesciences, LLC. Reason: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body..
Details
Source
Device Recall
External ID
Z-2080-2025
Action Date
2025-07-16
Status
Ongoing
Category
device
Product Description
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 Info: 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
Quantity Affected: 27022
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, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates (UAE), United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-14
Company
Irvine, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Edwards Lifesciences, LLC has 59 FDA actions in our database, including 35 recalls and 24 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Edwards Lifesciences, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Edwards Lifesciences, LLC have FDA actions?
Edwards Lifesciences, LLC has 59 FDA actions in our database, including 35 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2080-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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