Reported Jul 16, 2025 · Ongoing
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software…
Edwards Lifesciences, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- Brand NameOptisite
- Arterial Cannula Product NameOptisite
- Arterial Cannula Model/Catalog NumberOPTI18
- Software VersionN/A
- Product DescriptionCardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours
- ComponentNo
- Lot codes and dates
- Lot CodeModel
- NoOPTI18
- UDI00690103180565
- All lots up toBSLC9155
- Serial Numbers
92 of 92 codes
130451130466130472130593130709130764130818130821130847130948130952131038131043131047131182131193131231131236131289131311131317131433131435131513131516131553131554131606131623131625131628131682131737131909131929131966132175132201132366132395132416132430132435132505132832132958132959BSLC0110BSLC0166BSLC0661BSLC0661BSLC0826BSLC0826BSLC0826BSLC0826BSLC0855BSLC0855BSLC0887BSLC0887BSLC0979
- Amount recalled
- 13240
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Stop using this product now
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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