January 24, 2000St. 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
- 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
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
- 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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