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

Starting date:

February 9, 2016

Posting date:

February 26, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-57294

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  Reason
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  Affected products

Affected Products

A. ZILVER VASCULAR STENT WITH RAPID EXCHANGE

Reason

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

Affected products