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