Shelhigh Medical Devices Seized by FDA

April 2007

All implantable medical devices have been seized from Shelhigh, Inc., a New Jersey medical manufacturer. The Food and Drug Administration (FDA) and U.S. Marshals raided the facility because of deficiencies in Shelhigh’s production process that may compromise the safety of their products, specifically sterility.

Law requires that medical manufacturers follow certain requirements to ensure the safety of their devices. Shelhigh is guilty of producing products in a poorly constructed and unclean environment, failing to monitor the workplace for contamination, failing to properly sterilize products, and failing to provide evidence to support their expiration dates.

The safety of the following Shelhigh medical devices may be compromised:

• Shelhigh Pericardial Patch
• Shelhigh No-React Pericardial Patch
• Shelhigh No-React PneumoPledgets
• Shelhigh No-React VascuPatch
• Shelhigh No-React Tissue Repair Patch/UroPatch
• Shelhigh Pulmonic Valve Conduit No-React Treated
• Shelhigh No-React Dura Shield
• Shelhigh BioRing (annuloplasty ring)
• Shelhigh No-React EnCuff Patch
• Shelhigh No-React Stentless Valve Conduit
• Shelhigh Internal Mammary Artery
• Shelhigh Gold perforated patches
• Shelhigh Pre Curved Aortic Patch (Open)
• Shelhigh NR2000 SemiStented aortic tricuspid valve
• Shelhigh BioConduit stentless valve
• Shelhigh NR900A tricuspid valve
• Shelhigh MitroFast Mitral Valve Repair System
• Shelhigh BioMitral tricuspid valve
• Shelhigh Injectable Pulmonic Valve System

The FDA has requested that physicians monitor all patients with Shelhigh implants for infection and proper device function. Also, the agency advises doctors to consider alternative devices for prospective patients.