Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Num...
FDA Device Recall #Z-2081-2025 — Class I — May 14, 2025
Recall Summary
| Recall Number | Z-2081-2025 |
| Classification | Class I — Serious risk |
| Date Initiated | May 14, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Edwards Lifesciences, LLC |
| Location | Irvine, CA |
| Product Type | Devices |
| Quantity | 13240 |
Product Description
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
Reason for Recall
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Distribution Pattern
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.
Lot / Code Information
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
Other Recalls from Edwards Lifesciences, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2085-2025 | Class I | Brand Name: FEM-FLEXII Product Name: Femoral A... | May 14, 2025 |
| Z-2080-2025 | Class I | Brand Name: Optisite Arterial Cannula Product ... | May 14, 2025 |
| Z-2084-2025 | Class I | Brand Name: FEM-FLEX II Product Name: Femoral ... | May 14, 2025 |
| Z-2083-2025 | Class I | Brand Name: FEM-FLEX II Product Name: Femoral ... | May 14, 2025 |
| Z-2082-2025 | Class I | Brand Name: FEM-FLEX II Product Name: Femoral ... | May 14, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.