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FDA Alert: Shelhigh Implantable Medical Devices Seized

April 19th, 2007

"Shelhigh Implantable Medical Device Recalled"

This week, the U.S. Food and Drug Administration announced it would be seizing a number of implantable medical devices—including surgical patches, pediatric heart valves, and annuloplasty rings—from Shelhigh, Inc. due to the company's bad manufacturing practices. These practices have risked the safety and efficacy of the devices, and the FDA is urging doctors to monitor Shelhigh medical device patients for possible malfunctions and infection.

Seized Products

The following Shelhigh products are part of the seizure:

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

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