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FDA seizes all medical products from Shelhigh, Inc. due to violations
Weitz and Luxenberg is no longer accepting Shelhigh cases.
U.S. Food and Drug Administration (FDA) investigators and U.S. Marshals seized all implantable medical devices from Shelhigh, Inc., Union, N.J., after finding significant deficiencies in the company's manufacturing processes.
The deficiencies may compromise the safety and effectiveness of the Shelhigh products, particularly their sterility.
The Shelhigh products 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.
The tissue-based Shelhigh devices are used in many surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery.
Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these Shelhigh devices.
All medical device companies must follow current good manufacturing practice, a set of requirements that help
to ensure the safety and effectiveness of all medical
products.
Shelhigh's violations include:
Physicians should consider using alternative devices.
Physicians should also monitor patients with a Shelhigh implant for infections and proper device functioning over the expected lifetime of the device.
Patients who think they may have received a Shelhigh device during surgery should contact their physician for more information. FDA will issue a Preliminary Public Health Notification to physicians and other health care professionals and a Preliminary Advice for Patients shortly with more information; those documents will be posted to FDA's Web site.
The seizure follows an FDA inspection of the Shelhigh manufacturing facility last fall, as well as meetings with the company at which FDA warned Shelhigh that failure to correct its violations could result in an enforcement action.
FDA also alerted the company to its manufacturing deficiencies and other violations in two warning letters.
Medical devices manufactured by Shelhigh include:
If you were implanted with one of these devices and experienced an injury, our legal team may be able to assist you. Please complete the form below for a free legal review of your potential case. A representative of our firm will be in touch as soon as possible.
see also:
Shelhigh Seizure, 4.18.07
FDA Seizure of Implantable Medical Devices from Shelhigh in New JerseyFailure to properly test medical devices results in Shelhigh seizure
Shelhigh Implant
Shelhigh Stops Manufacture of Implant Due to Sterility ProblemsShelhigh implant at risk due to unsafe plant production--Lawsuit Info
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