S.m.a.r.t. Flex Biliary Stent System (2021-10-04)

Recall Summary The S.M.A.R.T. FLEX BILIARY STENT SYSTEM is being recalled in Canada because the stent may migrate or move from its intended position in the bile duct. This device is used to keep the bile duct open during medical procedures. The recall affects all units distributed across Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2021-10-15

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/5e4712fc-fa0f-4899-a79c-fe2a1b1f85a9