FDA labels IABP recall for Getinge ’ s Maquet, Datascope as Class I

The FDA today labeled a select recall of Getinge‘s (PINK:GETI B) Datascope and Maquet Cardiosave hybrid intra-aortic balloon pumps over issues related to fluid seepage and corrosion as Class I. A Class I recall is the federal watchdog’s most serious class of recall, indicating the potential for serious injury or death. The Cardiosave hybrid intra-aortic balloon pump is designed for use as a cardiac assist device for use with patients undergoing cardiac and non-cardiac surgery, as well as to treat patients with acute coronary syndrome or complications from heart failure, the FDA wrote in its release. The devices are being recalled over a design issue which could allow fluids to seep into the system which could result in corrosion of internal components including sensitive electronics. Such corrosion and seepage could cause delays or interruption in therapy, and could result in serious adverse health consequences, including death, according to the FDA. The recall affects all lots of devices with part numbers 0998-00-0800-XX & 0998-UC-0800-XX and cart 0997-00-1179 , but excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75, manufactured between December 12, 2011 and April 25, 2018 and distributed between March 6, 2012 and April 26, 2018, according to the FDA posting. Maquet instructed users to avoid placing fluids on top of the unit, ensure that saline containers and tubing do not hang over the device and, in case of accidental spillage, wipe the devic...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Assist Devices Cardiovascular Food & Drug Administration (FDA) Recalls Datascope Corp. Getinge Maquet Cardiovascular LLC Source Type: news