Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, and 0998-00-0800-55

There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir.

URGENT MEDICAL DEVICE CORRECTION dated 2/7/23 were sent to customers. There have been reported failures of the high pressure helium regulator which may cause a helium leak in the Cardiosave Hospital Cart. The high pressure helium regulator is located in the Cardiosave Hospital Cart and regulates the helium pressure of the external helium supply. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir. Please refer to images under Issue 3 for reference. Issue 3: Leak in the High Pressure Helium Regulator Identification of the issue: There have been reported failures of the high pressure helium regulator which may cause a helium leak in the Cardiosave Hospital Cart. The high pressure helium regulator is located in the Cardiosave Hospital Cart and regulates the helium pressure of the external helium supply. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir. Please refer to images below for reference. Datascope/Getinge has received 51 reported complaints of helium leak as a result of high pressure helium regulator failure over a 2 year period. There have been 0 adverse events reported. Risk to Health: Should a Cardiosave s helium supply be depleted due to an impaired helium pressure regulator, therapy may be interrupted. As with any therapy interruption, the degree of subsequent hemodynamic stability is related to the patient s overall clinical condition, those critically ill are more vulnerable to clinical decline. The risk of therapy interruption from a depleted helium supply is mitigated by the advanced notice provided to the User (a minimum of approximately 24 hours). The Pump Console s internal helium