Edwards Lifesciences, LLC Recall: Brand Name: Optisite Arterial Cannula Product Name: Opti
Edwards Lifesciences, LLC Recall: Brand Name: Optisite Arterial Cannula Product Name: Opti is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Edwards Lifesciences, LLC; Product: Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Soft
| Recalling firm | Edwards Lifesciences, LLC |
|---|---|
| Product | 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. |
| Reason for recall | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| 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, |
| Recall initiated | 20250514 |
| Recall number | Z-2080-2025 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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