FDA Seizes Implantable Devices
During a seizure of medical devices on April 17, 2007, FDA asked Shelhigh Inc., to voluntarily recall its products, but the company declined. On May 2, 2007, FDA issued a formal written request to Shelhigh Inc., to recall all of its medical devices remaining in the marketplace because of sterility concerns. FDA recommends that doctors and hospitals consider using alternative products. See "For More Information" below for a list of the company’s products.
Significant manufacturing deficiencies forced FDA investigators and U.S. Marshals on April 17, 2007 to seize all implantable medical devices made by Shelhigh Inc., Union, N.J. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility. Children, critically ill patients, and those whose immune systems may be compromised may be at greatest risk.
The types of products seized include pediatric heart valves and conduits (tube-like devices for blood flow); surgical patches; dural patches (to aid in tissue recovery after neurosurgery); annuloplasty rings (to help repair heart valves); and arterial grafts.
- Patients should contact their physicians if they think they may have received a Shelhigh device during surgery.
- Physicians should consider using alternative devices.
- Physicians should monitor patients with a Shelhigh implant for infections and proper functioning over the expected lifetime of the device.
- Patients and physicians should check FDA's Web site for: Preliminary Public Health Notification and Preliminary Advice for Patients Notification, both of which will offer more information.
- Shelhigh Pericardial Patch
- Shelhigh No-React Pericardial Patch
- Shelhigh No-React PneumoPledgets
- Shelhigh No-React VascuPatch
- Shelhigh No-React Tissue Repair Patch/UroPatch
- Shelhigh Pulmonic Valve Conduit No-React Treated
- Shelhigh No-React Dura Shield
- Shelhigh BioRing (annuloplasty ring)
- Shelhigh No-React EnCuff Patch
- Shelhigh No-React Stentless Valve Conduit
- Shelhigh Internal Mammary Artery
- Shelhigh Gold perforated patches
- Shelhigh Pre Curved Aortic Patch (Open)
- Shelhigh NR2000 SemiStented aortic tricuspid valve
- Shelhigh BioConduit stentless valve
- Shelhigh NR900A tricuspid valve
- Shelhigh MitroFast Mitral Valve Repair System
- Shelhigh BioMitral tricuspid valve
- Shelhigh Injectable Pulmonic Valve System
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Date Posted: April 30, 2007