Variuos Instruments from Gelweave Vascular Prosthesis (2014-07-08)

Starting date:

July 8, 2014

Posting date:

August 1, 2014

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-40813

• Reason
• Affected products

Recalled Products. 

A) Gelweave, Straight
B) Gelweave, Siena Collared Ante-Flo
C) Gelweave,Siena Collared 4 Branch Plexus
D) Gelweave, Bifurcate
E) Gelweave, Ante-Flo
F) Gelweave, Plexus 3-Branch
G) Gelweave, Valsalva
H) Gelweave, Ante-Flo with Collar
I) Gelweave, Arch Graft
J) Gelweave, Trifurcate

Reason

Vascutek is providing important user information regarding Gelweave Vascular Prosthesis. Currently Vascutek provides a high temperature cautery with each Gelweave vascular graft. Vascutek have decided to stop supplying the cautery with these product packs due to the cautery battery having a shorter shelf life than the graft.

Affected products