CLASS I ONGOING Device recall · Reported 16 Jul 2025 · FDA Enforcement Report
Optisite Arterial Cannula recalled by Edwards Lifesciences
Edwards Lifesciences is recalling Optisite Arterial Cannula, distributed nationwide in the US. The recall was initiated on 14 May 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2081-2025
- FDA event ID
- 96943
- Recalling firm
- Edwards Lifesciences, Irvine, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 14 May 2025
- FDA classified
- 10 Jul 2025
- Reported
- 16 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 14 May 2025 | Recall initiated by company | |
| 10 Jul 2025 | Classified by FDA | +57 days |
| 16 Jul 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Is Optisite Arterial Cannula recalled?
Yes. Edwards Lifesciences recalled Optisite Arterial Cannula on 14 May 2025. The recall is Class I and its status is Ongoing. Recall number Z-2081-2025.
Why was it recalled?
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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