AllClear
PricingSign in
FDAMay 14, 2025device

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 ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

edwards lifesciencesedwards

UPCs

00690103180565

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

Own something like this?

AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.

Start free — 200 items, no card →
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 ... — Recall Details · AllClear