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