In Safety warnings

Enter a keyword or phrase to search all pages in this section:


Advanced search

Archive:

Looking for a previously published document in this section?

MDA/2006/014 - Boston Scientific urological stone retrieval basket (1.9 Fr ZeroTip nitinol), catalogue numbers M0063901040 and M0063901050

Printer friendly version (new window)

Document details:

Type: Medical Device Alert
Series No: MDA/2006/014
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

Help viewing PDFs:

Page 1

Issued: 28 February 2006 at 12:45
Ref: MDA/2006/014

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Boston Scientific urological stone retrieval basket (1.9 Fr ZeroTip nitinol), catalogue numbers M0063901040 and M0063901050.

 >Page 2

Problem:
Potential for basket wire assembly to detach from drive wire during insertion procedure.

 >Page 2

Action by:
Urological surgeons, urological/general theatre staff and all staff responsible for purchasing.		  

Action:

  • Do not use affected retrieval baskets with batch numbers listed in the Appendix.
  • Quarantine any affected product for return to Boston Scientific.
  • Contact Boston Scientific for replacements.
  

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI) - Headquarters

* via CE Bulletin

 >Page 2

Contacts:
Details of manufacturer contacts and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.

 >Pages 2-3

Appendix:
List of affected batch numbers.

 >Page 4



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (Action underway): 21 March 2006
Deadline (Action complete): 11 April 2006


Page last modified: 07 February 2008