Editor’s Note: This article has been updated to include new information issued by the FDA on Thursday. The U.S. Food and Drug Administration (FDA) updated its Class I recall notice of the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) on Thursday to provide more detail. The updated notice states that the device may shut down unexpectedly due to failures in the printed circuit board assembly in the charging path. “If this occurs, the device may lose the ability to charge batteries in one or both battery bays/slots due to electrical surge damage in the Power Management Board Charging Path Circuit,” the new notice says. The updated notice adds more recommendations from device manufacturer Datascop/Maquet/Getinge’s Important Medical Device Advisory letter, which the company sent to all affected customers on June 5. These recommendations include not removing the battery when the battery level is 80% or higher and actively charging. If the battery “absolutely” must be removed before it is fully charged, the company says these directions should be followed: Connect the device catheter to an alternative IABP to maintain therapy. Turn off the Cardiosave device by pressing and holding the IABP power button. Unplug the IABP. Once disconnected from AC power, remove the battery using the detailed instructions provided in the Urgent Device Correction Letter. Original text posted Aug. 10: The Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) are the subject of a U.S. Food and Drug Administration (FDA) Class I recall, the most serious type, because of unexpected shutdowns, the agency announced Thursday. Use of devices subject to a Class I recall may cause serious injury or death, according to the FDA. Datascope/Maquet/Getinge, the devices’ manufacturer, issued the recall on June 5 because they may shut down unexpectedly due to electrical failures in the power management board or solenoid board. The FDA identified this as a Class I recall Thursday. Using these IABPs may cause serious adverse health events, including unstable blood pressure, inadequate blood supply, vital organ injury or death, the agency said. The manufacturer has reported 26 complaints, but none of those reports were of injury or death, according to the FDA. The devices provide temporary support to the left ventricle through counterpulsation. These IABPs are indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or heart failure complications in adults. Datascope/Maquet/Getinge’s Important Medical Device Advisory issued to all affected customers requested that they ensure they have an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other way to continue counterpulsation therapy. Anyone with questions should contact their representative with Datascope/Maquet/Getinge or call the manufacturer’s technical support line at (888) 943-8872, options 4, 2, 1, between 8 a.m. and 6 p.m. Eastern Time on weekdays. Adverse reactions or quality problems with these devices may be reported to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Image Credit: HstrongART – stock.adobe.com