St. Jude Medical, Inc. Recalls Heart Valve Products with Silzone CoatingJan 24, 2000 | www.safetyalerts.com
St. Jude Medical, Inc. announced today that on January 21 it had initiated a worldwide voluntary recall involving all products that have SilzoneÂ® coating. These products have a silver coating applied to the sewing cuff.
This recall does not affect St. Jude Medical products without the SilzoneÂ® 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 MedicalÂ® mechanical heart valves with SilzoneÂ® coated sewing cuffs.
St. Jude Medical is asking suppliers to discontinue the use of SilzoneÂ® coated products immediately. In addition suppliers should immediately inspect their inventory for any SilzoneÂ® products and quarantine them.