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ZILVER 518RX VASCULAR STENT RAPID EXCHANGE SELF-E (2015-12-22)
- Starting date:
- December 22, 2015
- Posting date:
- January 18, 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-56682
Affected Products
A. ZILVER 518RX VASCULAR STENT RAPID EXCHANGE SELF-E
Reason
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
A. ZILVER 518RX VASCULAR STENT RAPID EXCHANGE SELF-E
Lot or serial number
C912967
C930162
C930531
C939544
C967899
C974746
Model or catalog number
ZIVX5-18-125-6-20
ZIVX5-18-125-7-20
ZIVX5-18-125-7-30
ZIVX5-18-125-8-30
ZIVX5-18-125-9-40
Companies
- Manufacturer
-
COOK IRELAND LTD.
O'Halloran Road
National Technological Park
Limerick
IRELAND