News | April 17, 2007

FDA Seizes Shelhigh Implantables, Cautions Doctors to Monitor Patients for Infection

April 18, 2007 — Associated Press reports that on Tuesday U.S. marshals and FDA investigators began seizing heart valves and other implantable medical devices made from cow and pig tissue by a New Jersey company because of concerns about their sterility.

The FDA said it had found significant problems in the manufacturing processes at Shelhigh Inc., Union, NJ. It was estimated that one million animal parts and finished products were taken from Shelhigh Inc., Union, NJ, according to spokeswoman Heidi Rebello.

The seized products include pediatric heart valves and conduits, as well as surgical patches, arterial grafts and annuloplasty rings used to help repair heart valves.

The seizure followed an inspection of the company by the FDA last fall. The agency also warned Shelhigh about the problems during meetings and in two warning letters, sent in 2000 and 2005. The earlier letter cited multiple reports of infections and other problems with some of Shelhigh's products.

The tissue-based devices are used in many surgeries, including open-heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery, the FDA said. Critically ill patients, pediatric patients and patients with weakened immune systems may be at greatest risk from the use of these devices, it added.

The FDA recommended doctors consider using alternative devices. Also, doctors should monitor patients with a Shelhigh implant for infections and proper functioning.

Related Content

Medtronic Announces TAVR Study of Aortic Stenosis Patients With Bicuspid Valves
News | Heart Valve Technology | September 19, 2018
The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) to initiate a new...
4C Medical's AltaValve First-in-Human Experience to be Presented at TCT 2018
News | Heart Valve Technology | September 17, 2018
September 17, 2018 — 4C Medical Technologies Inc.
Gore Acquires Pipeline Medical Technologies Inc.
News | Heart Valve Technology | September 06, 2018
W. L. Gore & Associates Inc. (Gore) announced the acquisition of Pipeline Medical Technologies Inc., a privately...
The Edwards Lifesciences Cardioband Tricuspid Valve Reconstruction System received the European CE mark approval in May.

The Edwards Cardioband Tricuspid Valve Reconstruction System received the European CE mark approval in May, becoming the first transcatheter tricuspid repair device to be approved in the world.

Feature | Heart Valve Technology | August 21, 2018 | Jeff Zagoudis
The tricuspid valve has been dubbed “the forgotten valve” by many practitioners in the interventional cardiology spac
Earlier Intervention for Mitral Valve Disease May Lead to Improved Outcomes
News | Heart Valve Technology | July 26, 2018
The number of patients undergoing mitral valve operations are at an all-time high, and new research suggests many...
The Abbott Tendyne transcatheter mitral valve replacement (TMVR) system  is being tested in the SUMMIT Trial.

The Abbott Tendyne transcatheter mitral valve replacement (TMVR) system.

Feature | Heart Valve Technology | July 26, 2018
July 26, 2018 — The pivotal clinical study in the U.S.
A CoreValve TAVR valve seen in a CT scan looking down from the aortic arch into the left ventricle using reconstruction software from TeraRecon.

A CoreValve TAVR valve seen in a CT scan looking down from the aortic arch into the left ventricle using reconstruction software from TeraRecon.

Feature | Heart Valve Technology | July 26, 2018
July 26, 2018 — A new multi-societal expert consensus document has been released that summarizes the position of thes
Abbott Receives FDA Approval for Third-Generation MitraClip Device
Technology | Heart Valve Technology | July 18, 2018
July 18, 2018 — Abbott announced it received approval from the U.S.
Videos | Heart Valve Technology | July 18, 2018
Jonathon Leipsic, M.D., FSCCT, professor of radiology and cardiology at the University of British Columbia, Vancouver
Videos | Heart Valve Technology | July 10, 2018
Ori Ben-Yehuda, M.D., executive director of the Cardiovascular Research Foundation Clinical Trial Center, discusses t
Overlay Init