Dangerous Shelhigh Implantable Medical Devices Seized by FDA

US Food and Drug Administration investigators and US Marshals have seized all implantable medical devices from Shelhigh, Inc. after finding significant deficiencies in the company's manufacturing processes. The deficiencies could compromise the safety and effectiveness of the products, particularly their sterility.

Shelhigh is accused of having a badly constructed and poorly maintained clean room, failing to adequately monitor for microbial contamination, failing to properly test sterility and failing to properly monitor product expiration dates.

Medical devices made by Shelhigh:

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

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

Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices.

The FDA is recommending that doctors use alternative devices in future surgeries and monitor any patients with a Shelhigh implant for infections.

Patients who have received a Shelhigh device during surgery are advised to contact their doctors.

Shelhigh Devices Articles

The Shelhigh Story: Lawsuits, Infections and Spin-Doctoring Part II
Shelhigh Medical Devices, the Union, NJ, manufacturer of tissue-based medical devices, virtually shut down by court order in a lawsuit started by the Food and Drug Administration in April, wants to keep you in the dark. Shelhigh wants you to believe that its products won't cause infection in surgery patients, and that it has been framed by the mean old FDA.

The Shelhigh Story: Lawsuits, Infections and Spin-Doctoring Part I
If you listen to the makers of Shelhigh Medical Devices, the company which was virtually shut down by the Food and Drug Administration in April of this year, you would think the company is a poor innocent victim of a vendetta by the FDAâ€"that the potential for infection from its products and lawsuits by the injured has all been manufactured out of thin air.

Shelhigh Medical Devices agrees to FDA Terms - Part Two
Shelhigh Medical Devices Agrees to FDA Terms
Battle of Device Maker Shelhigh and FDA Rages On - Part II
Battle of Device Maker Shelhigh and FDA Rages On Part I
Shelhigh and the FDA: David vs. Goliath
Shelhigh Tries a New Tact
Shelhigh Fighting the FDA
Shelhigh and FDA Play Blame Game Over Sale of Contaminated Devices
Knock, Knock, Knocking on Shelhigh's Door
Non-Sterile Environment at Shelhigh Shocking
Shelhigh Raid and Seizure from the FDA
Shelhigh Devices Seized by FDA

Shelhigh Medical Devices in the News

JUN-25-07: At least two hospitals stopped using Shelhigh's products after the FDA's seizure of the company's devices was announced. The FDA asked Shelhigh to recall all its products, but Shelhigh refused to comply. [BIZ: SHELHIGH]

JUN-25-07: Shelhigh and the FDA have reached a settlement that requires independent experts to inspect and certify Shelhigh's manufacturing processes. Until the inspection is complete, Shelhigh will not distribute implantable medical devices. [STAR-LEDGER: SHELHIGH]

JUN-01-07: FDA investigators documented deficiencies in Shelhigh's facilities in 2000 and 2005, and sent a number of warning letters before taking action against the medical device manufacturer. [MEDGADGET: SHELHIGH]

MAY-31-07: A federal judge has ruled that certain items seized by health officials will not be released to Shelhigh because of concerns about sterility and health risks. A hearing to determine the safety of the devices will be held before any items can be released. [STAR-LEDGER: SHELHIGH]

MAY-16-07: A judge has told Shelhigh not to count on getting back inventory that was seized by the FDA. The inventory was seized due to concerns about sterility and health risks associated with the products. [STAR-LEDGER: SHELHIGH]

MAY-13-07: Shelhigh plans to fight the FDA's recall of its products, claiming the FDA is being unreasonable in forcing the quarantine. [STAR-LEDGER: SHELHIGH]

MAY-01-07: The FDA has formally requested that Shelhigh recall all of its medical devices that are still in the marketplace because of concerns about their sterility. [FDA NEWS: SHELHIGH]

APR-18-07: Shelhigh, Inc. is accused of manufacturing products with potentially fatal disregard for cleaning, contamination, and sterility. [IMEDNEWS: SHELHIGH DEVICES SEIZED]

APR-18-07: An estimated 1 million parts and finished products, made from cow and pig tissue, have been seized from Shelhigh, Inc. because of concerns about their sterility. [AHN: DEFECTIVE DEVICES SEIZED]

APR-17-07: FDA seizes all implantable medical devices from Shelhigh, Inc. due to concerns that deficiencies in their manufacturing process may pose serious risks to patients. [STAR LEDGER: DEFECTIVE MEDICAL DEVICES]

Shelhigh Defective Medical Devices Legal Help

If you or a loved one has had complications after having any of the above devices implanted, please click the link below to send your complaint to a lawyer to evaluate your claim at no cost or obligation.
Last updated on Aug-9-07