Shelhigh is known for producing some of the best and most lauded medical devices available for the last ten years, but problems with repeated contamination at Shelhigh's single facility in Union, NJ not only caused a recent FDA 'recall' but these continued contaminations during the manufacturing process have potentially put at risk those patients who have been implanted with Shelhigh devices. |
Medical devices manufactured by Shelhigh include: Pericardial Patch, No-React Pericardial Patch, No-React PneumoPledgets, No-React VascuPatch, No-React Tissue Repair Patch/UroPatch, Pulmonic Valve Conduit No-React Treated, No-React Dura Shield, BioRing (annuloplasty ring), No-React EnCuff Patch, No-React Stentless Valve Conduit, Internal Mammary Artery, Gold perforated patches, Pre Curved Aortic Patch (Open), NR2000 SemiStented aortic tricuspid valve, BioConduit stentless valve, NR900A tricuspid valve, MitroFast Mitral Valve Repair System, BioMitral tricuspid valve and Injectable Pulmonic Valve System. |
Many of these devices are used for seriously-ill patients, such as open heart surgery for adults, children, and infants, and repairing soft tissue during neurosurgery. Because of the lack of sterility of the medical devices, patients who have been implanted with Shelhigh devices are at heightened risk of worsening health. |