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IntraStent Unmounted Balloon Expandable Stent

Notice type: Recall

Date: 24/01/2008

  

Product name or type:
IntraStent Unmounted Balloon Expandable Stent

Reference:
SN2008(01)

Manufacturer Or Supplier:
Ev3, United Kingdom

Serial Or Batch Number And Expiry Date:
4206244, 1688027, 1979986, 3003378

Target Audience:
Hospital Chief Executive Officers, Hospital Risk Managers, Vascular Surgery, Gastrointestinal Surgery, Gastroenterology, Interventional Radiology, Surgical Departments

Problem Or Issue:
The manufacturer, ev3, has advised the Irish Medicines Board (IMB) of a recall of specific lots of the IntraStent Unmounted Balloon Expandable Stent.   

The manufacturer has confirmed that the following affected lot / serial numbers have been supplied to the Irish market:   

4206244, 1688027, 1979986, 3003378

Background Information Or Related Documents:
The IntraStent is a peripheral / biliary stent.

The manufacturer initiated the recall of certain lots of this product following the discovery that two symbols (the symbol for length and the symbol for diameter) on the side and end-flaps of IntraStent boxes in the affected lots are reversed.  The length and diameter symbols on the top of the box and on the device pouch are correct.
 
The potentially affected lots of this product were supplied to the Irish market in the year 2007 by Lecks Medical.

No action is required with devices that have already been implanted.

IntraStent Unmounted Balloon Expandable Stent Document

Actions To Be Taken:
  1. Ensure that the relevant personnel in your organisation are made aware of this recall.
  2. Determine if you have purchased the affected lots of this product.
  3. Quarantine and return any unused affected product to ev3, United Kingdom office (see address below).
  4. Advise the IMB if you have the affected product.

Further Information:
All adverse incidents relating to a medical device should be reported to the:   

Health Products Regulatory Authority
Medical Devices Department 
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2   

If you have any enquiries, you may contact the Medical Devices Department at:   

Telephone: +353-1-6764971 
Fax:           +353-1-6344033 
Email:        vigilance@imb.ie 
Website:     www.hpra.ie   

Enquiries to the manufacturer should be addressed to:
   
Ms. Paula O’Sullivan
ev3 Limited
1 Twyford Business Centre
London Road
Bishop’s Stortford
Herts, CM23 3YT
United Kingdom

Telephone:   +44-1-279-659-900        
Fax:             +44-1-279-654-900                    
Email:          posullivan@ev3.net

IntraStent Unmounted Balloon Expandable Stent

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