Warning Letter Prompts Product Recall at Vascular Device Manufacturer

A company that manufactures vascular grafts and fabrics is more than halfway through a product recall triggered by the improper storage of various Hemashield devices.

No patients have been harmed by the potentially defective Hemashield products, said Christian Keller, president and CEO of Maquet Cardiovascular LLC. He would not discuss the cost of the recall or specify the number of devices involved. Maquet is part of the publicly-listed Swedish group of companies, GETINGE AB, with the Maquet brand representing the Medical Systems Business Area. Maquet has three specialty divisions—Critical Care, Cardiovascular and Surgical Workplaces; the Cardiovascular branch is headquartered in Wayne, N.J.

A warning letter from the U.S. Food and Drug Administration (FDA) reprimands Maquet for, among other failures, improperly storing several different kinds of Hemashield products (its Platinum Woven and knitted Double Velour Vascular grafts as well as the Gold Woven and knitted Double Velour grafts). According to the Aug. 11 letter, the former owner of Maquet—Boston Scientific Corp. of Natick, Mass.—had notified customers in 2006 about reports of droplets of glycerol (used in a collagen coating on the products) appeared inside packages that may have been exposed in a warehouse to high heat and humidity. The glycerol droplets could potentially compromise patient safety. The FDA criticized Maquet for failing to report that notification to regulators.

The FDA also cited other violations, including the adulteration of devices, the lack of cleaning validation and misbranding. Government inspectors claimed that Maquet’s methods to manufacture, package, store or install its devices do not comply with the FDA’s Good Manufacturing Practice requirements.

In addition, Maquet allegedly failed to perform a cleaning validation on its cleaning of vessels, surfaces and other equipment used to coat its products with collagen. “Your firm’s laboratory simulation Disinfectant Efficacy Testing report shows that the disinfectants used by your firm can remove microorganisms placed on carrier test coupons,” the warning letter stated. “However, no cleaning validation study was conducted to demonstrate that your cleaning and sanitizing procedures are adequate in removing contaminates from actual collagen processing equipment.”

Keller told The Record of Hackensack, N.J., that his firm responded to the FDA’s allegations and “put together programs to address” the issues.