Zilver Vascular Stent With Rapid Exchange (2016-02-09)

ZILVER Vascular Stent Recall Summary Cook Medical is recalling ZILVER vascular stents with rapid exchange catheter systems distributed across Canada due to a manufacturing defect that could cause the stent to detach from the delivery catheter during placement. This defect affects stents manufactured between specific dates and could result in incomplete stent deployment or stent loss. The recall applies to healthcare facilities and hospitals that received these devices across Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2016-02-26

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/d06b415b-9203-41c8-80a7-483790aa3455