Maquet, the medical device subsidiary of Getinge (PINK:GETI B), is recalling some of its intra-aortic balloon pumps after receiving more than 100 reports that the device shut down without warning, leading in 1 case to a patient’s death.
The IABP device is designed to inflate a balloon placed in the thoracic aorta to assist the heart during emergency cardiac support. Maquet warned customers March 21 about a problem with its IABP’s fan assembly, saying a misshapen retaining ring "could separate within the fan assembly, causing the fan to stop rotating. This could result in the power supply overheating and the IABP would shut down without any warning," according to the FDA.
"This device failure would cause the balloon to stop inflating and deflating. It may result in decreased blood flow to the heart and the rest of the body, difficulty in weaning the patient from cardiopulmonary bypass, and clotting or blockage of blood vessels to the intestines, kidneys, or legs. The possible long range consequences of this include organ injury or tissue damage, possibly leading to patient death," according to the FDA, which said the recall is Class I, its most serious recall designation. "The firm received 106 reports of device malfunctions. There were zero injuries and 1 death."
The FDA said customers can continue using recalled pumps, but should make sure a backup pump is immediately available. Maquet plans to replace the fan assemblies in the affected devices, according to the federal watchdog agency.
The recall covers Maquet’s System 98/98XT, CS100/CS100i and CS300 IABPs (model numbers: 0998-00-0446-xx, 0998-UC-0446-xx, 0998-00-0479-xx, 0998-UC-0479-xx, 0998-UC-0446Hxx, 0998—00-3013-xx, 0998-UC-3013-xx, 0998-00-3023-xx, 0998-UC-3023-xx) and various lot numbers, the FDA said. Affected products were made between Jan. 1, 2003, through June 30, 2011, and distributed from Jan. 17, 2003 through June 30, 2011, the agency said.