FDA Seizes Cardiac Valves, Other Implantable Devices

Poor manufacturing standards compromised device sterility at New Jersey company

WEDNESDAY, April 18 (HealthDay News) -- The U.S. Food and Drug Administration and U.S. Marshals seized all implantable medical devices this week that were manufactured by Shelhigh Inc., of Union, N.J., including pediatric heart valves and conduits, surgical patches, dural patches, annuloplasty rings and arterial grafts.

The FDA took the action in response to an inspection of Shelhigh's manufacturing facility last fall that revealed problems, particularly related to sterility, that could affect patients and the efficacy of the devices. In addition to a number of sterility-related violations, the FDA also said Shelhigh had failed to back up its expiration dates with scientific data.

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

Physicians are advised to avoid using the Shelhigh devices and to monitor patients already using them for the expected life of the implant. More information for both physicians and patients will be posted on the FDA's Web site soon, the agency said.

After last year's inspection, the FDA met with management and "warned Shelhigh that failure to correct its violations could result in an enforcement action. FDA also alerted the company to its manufacturing deficiencies and other violations in two warning letters," according to an FDA statement.

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