Maquet Datascope Corp., is recalling more than 2,800 CARDIOSAVE Hybrid Intra-aortic Balloon Pumps (IABPs) distributed nationwide due to a design defect that can lead to pump malfunction, which could result in serious and potentially fatal health consequences to patients. The recall is listed as a Class I, which is the most serious type of recall. Use of these devices may cause serious injuries or death.
CARDIOSAVE Hybrid Intra-aortic Balloon Pumps (IABPs) are cardiac-assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure. Marquet Datascope is recalling the heart pump due to a design issue that allows fluid, such as saline, to seep into the device. The fluid can cause corrosion of internal components such as the electronic circuit boards, and cause the device to stop suddenly, which can cause a delay or interruption in therapy.
The recall affects all lots of the CARDIOSAVE Hybrid Intra-aortic Balloon Pump, which were distributed from March 6, 2012, to April 26, 2018.
Marquet Datascope issued an Urgent Medical Device Correction letter to all device consignees with instructions on how to reduce the risk of this design defect resulting in injury, such as not placing fluids on top of the unit, ensuring that the saline container and tubing do not hang directly over the IABP, and, in the event of accidental spillage, to wipe clean immediately and have the unit serviced to ensure no hazard exists.
Any adverse events or quality problems with this IABP should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice