Devices

Device Recall IntraStent DoubleStrut LD Biliary Stent

Model / Serial
Model S15-36, lot no. 494428
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
AR, GA, IN, MA, TN, and UT
Product Description
IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The IntraStent DoubleStrut LD Biliary Stent is a balloon expandable stent. It is intended as a permanently implanted device. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is designed to be crimped onto a non-compliant PTA balloon catheter that is indicated for biliary stent expansion. After mounting onto a balloon catheter, it is deployed and expanded by inflating the balloon.
Manufacturer
Ev3, Inc
1 Event
- Recall of Device Recall IntraStent DoubleStrut LD Biliary Stent

Manufacturer

Ev3, Inc

Manufacturer Address
Ev3, Inc, 4600 Nathan Ln N, Plymouth MN 55442-2890
Source
USFDA

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