Reported Aug 21, 2013 · Terminated
Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit…
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 · 12050 Lone Peak Pkwy · Draper, UT · 84020-9414
Is this the product you have?
- Edwards EndoReturn Arterial Cannula
- model ER21B and ER23B Product UsageThe ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector hub. The ThruPort catheter introducer sheath kit includes a wire reinforced cannula with hemostasis valve, an introducer, and a guidewire. The cannulae have a wire reinforced section to provide kink resistance and flexibility, tapered tips to aid in insertion and advancement into the femoral artery, a non-reinforced clamp site, a 3/8 in. (9.5 mm) barbed connector, and a hemostasis valve (available on some versions) that allows passage of catheters, such as the EndoClamp aortic catheter. The introducers accept a .038 in. (0.97 mm) guidewire and are marked to simplify assembly and indicate alignment. On some versions, a connector hub secures and immobilizes the introducer within the cannula for easier, one person insertion of the cannula/introducer assembly
- Lot codes and dates
- Model ER21B Lots
594969845951693359516936595313855953138659543708
- Model ER23B Lots
59464327594843495948435059484351595121465951327259516940595344305953573959541763
- Model ER21B Lots
- Amount recalled
- 855
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- VA
Why it was recalled
Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance problem with the IntraClude IntraAortic Occlusion device.
This product could cause temporary or reversible health problems — stop using it.
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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