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FDA Seizes Implantable Devices

Update (May 2, 2007):
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. For a list of the company’s products, visit www.fda.gov/cdrh/safety/041907-shelhigh.html

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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.

FDA Recommendations

Products Seized

For more information, visit
www.fda.gov/cdrh/medicaldevicesafety/atp/041907-shelhigh.html

Date Posted: April 30, 2007

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