Product Wiki · Recalls · Health Canada — Medical Devices

ZILVER VASCULAR STENT WITH RAPID EXCHANGE (2016-02-09) — recall 54977

Health Canada — Medical Devices · Canada · 2016-02-26 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54977
Date of alert
2016-02-26
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Testing demonstrates a process used to manufacture the inner catheter to stylet joint of the delivery system doesn't meet the required specification on a consistent basis and there is a risk the joint may separate during deployment. A failure of this joint would represent a device malfunction and were it to occur during a procedure may result in a partial stent deployment. The clinical effect of a partial deployment may be a need for surgical intervention, or may result in vessel trauma or an embolic event
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/zilver-vascular-stent-rapid-ex

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