FDA seized all implantable medical devices from Shelhigh, Inc., after finding significant deficiencies in the company’s manufacturing processes.
The tissue-based 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.
The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility. Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices.
Physicians should use alternative devices. Physicians should also monitor patients with any Shelhigh implants 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.