The FDA recalled vascular devices made by Maquet Cardiovascular LLC and Millar Instruments Inc.
The federal watchdog agency classified the recalls as Class I, its most serious level of product clawback, indicating a reasonable probability that the use of the recalled product "will cause serious adverse health consequences or death."
The recalled Marquet device is the Heartstring II proximal seal system, model number HS-1045, for which the company sent out an "Urgent Device Removal" letter on May 5, 2010. The FDA posted the Class I recall notice on its website yesterday. The recall affects lot numbers 12895788, 12946718, 25002866, 25004647, 13029141, 25005045 and 25005622, distributed from Sept. 2009 through April 2010, according to the FDA.
The Wayne, N.J.-based company’s Heartstring II is designed to help control the flow of blood in the aorta during coronary artery bypass surgery. It gives surgeons the ability to create an important connection between blood vessels (proximal anastomosis) without the use of an aortic clamp, according to the FDA. The device was recalled because its deployment tube may detach during use.
Millar pulled its Mikro-Tip angiographic catheter off the shelves and notified its customers of a possible defect in the device earlier this month.
The Houston-based company found that the lumen component of models SPC-454D and SPC-454F of its angiographic catheter contain particulates that could enter the blood stream and cause heart attack, stroke, limb ischemia and death.
A total of 965 catheters were distributed internationally and 115 catheters were distributed to Millar customers in California, Washington, D.C., Massachusetts, Michigan, Minnesota, New York and Pennsylvania.
The FDA also posted the Class I recall notice for the Millar catheter March 31.