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The Food and Drug Administration has asked Shelhigh, Inc. to conduct a recall of its implantable medical devices still on the market, even those in hospital inventories, because of safety issues.

According to the FDA, the company's manufacturing processes may have compromised the safety—particularly the sterility—of the medical products. Last month, the agency requested U.S. Marshals to seize all medical devices from the company's manufacturing facility in Union, New Jersey.

Shelhigh was asked at the time of the seizure to issue a voluntary recall of its products on the market, but the company refused the request.

Yesterday, the FDA sent the company a formal written request. In the meantime, the agency is recommending that doctors and hospitals discontinue use of the devices, which include heart valves, dural patches, and annuloplasty rings and are used in babies, children, and adults for various surgical procedures.

“Since these are critical devices implanted into seriously-ill patients, ensuring their sterility is absolutely essential to prevent infection. FDA will continue to provide up-to-date information to patients and physicians about this ongoing public health matter,” said Dr. Daniel Schultz, agency official.

Patients who experience serious health effects because of a Shelhigh medical device are encouraged to make a report to the FDA's MedWatch program.

(Source: FDA website)

Injured by a Shelhigh medical device? You may be able to hold the manufacturer liable for your losses. Contact us today to learn more about your legal rights and options.