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SafetyAlerts
January 24, 2000

St. Jude Medical, Inc. Recalls Heart Valve Products with Silzone® Coating

St. Paul, MN (SafetyAlerts) - St. Jude Medical, Inc. announced today that on January 21 it had initiated a worldwide voluntary recall involving all products that have Silzone® coating.  These products have a silver coating applied to the sewing cuff.

This recall does not affect St. Jude Medical products without the Silzone® coating.

St. Jude Medical has received information which indicates a statistically significant higher rate of paravalvular leak leading to valve explants in patients implanted with St. Jude Medical® mechanical heart valves with Silzone® coated sewing cuffs.

St. Jude Medical is asking suppliers to discontinue the use of Silzone® coated products immediately. In addition suppliers should immediately inspect their inventory for any Silzone® products and quarantine them.

Quarantined products should immediately be returned to:

St. Jude Medical,
One Lillehei Plaza,
St. Paul, MN 55117
Attention: Silzone® Product Return

For purposes of returning Silzone® coated product, use St. Jude Medical's Federal Express Account Number, 055406871, and request Priority Overnight Service so that St. Jude Medical will cover the cost of the return shipment.  You do not need a return authorization number.

For a complete listing of products, questions and answers for heart patients and additional instructions, you can visit the St. Jude website at
http://www.sjm.com/stjude/common/htm/frm_sil.htm

Should you have any questions regarding this matter, please contact the following numbers:

  • For questions regarding the return of recalled product and replacement product contact St. Jude Medical's Customer Service Department at 800/544-1664.
  • For any technical related questions on this product recall, contact St. Jude Medical's Technical Assistance Hotline at 800/922-9219.
 
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Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.