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FDA seizes all implantable devices from Shelhigh, Inc.

Ambulatory Surgery Reimbursement Update, April 24, 2007

The U.S. Food and Drug Administration (FDA) seized all implantable medical devices April 17 from Shelhigh, Inc. in Union, NJ, according to a press release from the FDA.

The FDA seized the devices after finding "significant deficiencies in the company's manufacturing processes. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility," according to the release.

The seized products include pediatric heart valves and conduits, surgical patches, dural patches, annuloplasty rings, and arterial grafts.

According to the FDA, Medical devices manufactured by Shelhigh include the Shelhigh

• Pericardial Patch
• No-React Pericardial Patch
• No-React PneumoPledgets
• No-React VascuPatch
• No-React Tissue Repair Patch/UroPatch
• Pulmonic Valve Conduit No-React Treated
• No-React Dura Shield
• BioRing (annuloplasty ring)
• No-React EnCuff Patch
• No-React Stentless Valve Conduit
• Internal Mammary Artery
• Gold perforated patches
• Pre Curved Aortic Patch (Open)
• NR2000 SemiStented aortic tricuspid valve
• BioConduit stentless valve
• NR900A tricuspid valve
• MitroFast Mitral Valve Repair System
• BioMitral tricuspid valve
• Injectable Pulmonic Valve System

To view the FDA press release, which includes instructions for physicians who use Shelhigh devices and patients who may have received a Shelhigh device during surgery, click here.

To view the FDA's preliminary public health notification on the seizure, click here.

For more information on the seizure, read coverage from the Associated Press by clicking here.

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