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Anaconda Body Delivery Systems (2013-10-21)
- Starting date:
- October 21, 2013
- Posting date:
- November 29, 2013
- 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-36923
Recalled Products
A. Anaconda Bifurcate Body Stent
B. Anaconda One-Lok Bifurcate Body
Reason
Vascutek has received 3 complaints (with an occurrence rate of 0.1%) where the release wire of an Anaconda Body Delivery system has fractured following stent deployment. Two of these three incidents resulted in conversion to open repair. The manufacturer is recalling all Anaconda bodies. Previously implanted stents are not affected by this recall.
Affected products
A. Anaconda Bifurcate Body Stent
Lot or serial number
All serial numbers
Model or catalog number
B19
B21
B23
B25
B28
B30
B32
B34
Companies
- Manufacturer
-
Vascutek Ltd.
Newmains Avenue, Inchinnan Industrial Estate
Renfrewshire, Scotland,
PA4 9RR
UNITED KINGDOM
B. Anaconda One-Lok Bifurcate Body
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
OLB21
OLB23
OLB25
OLB28
OLB30
OLB32
OLB34
Companies
- Manufacturer
-
Vascutek Ltd.
Newmains Avenue, Inchinnan Industrial Estate
Renfrewshire, Scotland,
PA4 9RR
UNITED KINGDOM