VENOVO VENOUS STENT SYSTEM (2021-01-18)

Starting date:

January 18, 2021

Posting date:

February 5, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-74931

Last updated:
2021-08-24

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  Reason
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  Affected products

Affected Products 

VENOVO VENOUS STENT SYSTEM

Reason

Bd received reports on the venovo venous stent system indicating that the proximal end of the stent does not immediately expand upon deployment but remains connected to the stent cushion on the delivery system. An illustration of the proximal section adhered to the stent cushion may be seen in the customer notification.If the proximal end of the stent does not immediately expand upon deployment, over-manipulation or forcing the catheter delivery system, as well as use of other intravascular devices or techniques to assist the stent's expansion, could potentially have a varying degree of harm associated with it. Potential harm ranges from prolonging the procedure, damaging or deformity of the stent, potential vascular injury and/or hemodynamic disruption affecting the blood flow and / or a thrombotic event. In cases where the stent self-expanded, there is no incremental risk of harm. In addition, investigative studies of subject test samples have observed traces of cushion material (medical grade and biocompatible silicone) firmly adhered to the surface of the stent strut only where the stent cushion comes in contact with the stent.

Affected products