Devices

Device Recall Edwards EndoReturn Arterial Cannula, model ER21B and ER23B

Model / Serial
Model ER21B Lots: 59496984, 59516933, 59516936, 59531385, 59531386 , 59543708 Model ER23B Lots: 59464327, 59484349, 59484350, 59484351, 59512146, 59513272, 59516940, 59534430, 59535739, 59541763
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide including Canada and VA sites.
Product Description
Edwards EndoReturn Arterial Cannula, model ER21B and ER23B || Product Usage: || The 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.
Manufacturer
Edwards Lifesciences, LLC
1 Event
- Recall of Device Recall Edwards EndoReturn Arterial Cannula, model ER21B and ER23B

Manufacturer

Edwards Lifesciences, LLC

Manufacturer Address
Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
Manufacturer Parent Company (2017)
Edwards Lifesciences Corporation
Source
USFDA

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