| On May 2, 2007 the FDA issued a formal demand | | | | |
| of Shelhigh, Inc. to recall all of its | | | | - Shelhigh BioRingT (annuloplasty ring) |
| medical devices due to concern of | | | | |
| contamination. On April 17, 2007 the FDA | | | | - Shelhigh GoldT perforated patches |
| requested a voluntary recall by Shelhigh, | | | | |
| Inc., after a seizure operation by the U.S. | | | | - Shelhigh Internal Mammary Artery |
| Marshals, but the company refused. The FDA | | | | |
| requested that the U.S. Marshals seize any | | | | - Shelhigh No-React Dura Shield |
| devices and components from Shelhigh's Union, | | | | |
| New Jersey facility. The seizure was prompted | | | | - Shelhigh No-React EnCuff Patch |
| by the discovery of significant deficiencies | | | | |
| in the company's manufacturing process. | | | | - Shelhigh No-React Pericardial Patch |
| | | | |
| The FDA sent two warning letters prior to the | | | | - Shelhigh No-React PneumoPledgets |
| official seizing of their property and even | | | | |
| after requesting a voluntary recall, the | | | | - Shelhigh No-React VascuPatch |
| company refused. If they are to refuse the | | | | |
| most recent order for recall, the FDA can | | | | - Shelhigh No-React Stentless Valve Conduit |
| seek a court order mandating the recall. | | | | |
| | | | - Shelhigh No-React Tissue Repair Patch |
| It is unfortunate that it takes so much | | | | UroPatchT |
| convincing for a company to recall its | | | | |
| products, when they have been proven to be | | | | - Shelhigh Pericardial Patch |
| unsafe. For a company that manufacturers | | | | |
| medical devices which are placed in sick and | | | | - Shelhigh Pre Curved Aortic Patch (Open) |
| injured patients' hearts, it is highly | | | | |
| alarming that they would put up such a fight | | | | - Shelhigh Pulmonic Valve Conduit No-React |
| after learning their products were doing more | | | | Treated |
| harm than good. | | | | |
| | | | - Shelhigh BioConduitT stentless valve |
| In an earlier inspection from the FDA of | | | | |
| Shelhigh's New Jersey plant, they found "a | | | | - Shelhigh BioMitralT tricuspid valve |
| number of sterility test failures". They put | | | | |
| out a warning to doctors informing them that | | | | - Shelhigh Injectable Pulmonic Valve System |
| the way the devices were manufactured may | | | | |
| have "contaminated" the devices with | | | | - Shelhigh MitroFast Mitral Valve Repair |
| "bacteria, fungi or endotoxin." | | | | System |
| | | | |
| The marketing director of Shelhigh, Inc., | | | | - Shelhigh NR2000 SemiStentedT aortic |
| Douglas Goldman, stated that the FDA had no | | | | tricuspid valve |
| proof or data to justify the demand and | | | | |
| therefore "no recall is in effect". | | | | - Shelhigh NR900A tricuspid valve |
| | | | |
| The following is a list of products | | | | - Endura No-React Dural Substitute* |
| manufactured and distributed by Shelhigh, | | | | |
| Inc. These products are used for open heart | | | | *(Note: This is a private label device. |
| surgery in adults, children and infants, and | | | | Shelhigh, Inc. manufactured it. Integra Corp. |
| to repair soft tissue during neurosurgery and | | | | marketed it. |
| abdominal, pelvic and thoracic surgery. | | | | |