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 device clean immediately and have the unit serviced to avoid hazards.
If an interruption occurs, Maquet suggested users transfer patients to an alternative IABP. If an alternative is not available, the company suggested manual inflation of the IAB with air or helium and immediate aspiration, repeated every five minutes until either an alternate IABP is available or removal of the device.
Maquet said it will contact affected customers to resolve the issues, and that it expects to have a protective top cover for the devices available later this month.
Last June, the FDA released information on a select voluntary recall of Getinge’s Datascope and Maquet System CS100, CS100i and CS300 intra-aortic balloon pumps over issues with potential electrical test failures.