Rachel Klemovitch, Assistant Editor03.05.24
TÜV SÜD has temporarily suspended the CE certificate for Getinge’s Cardiosave Intra-Aortic Balloon Pump, effective immediately. The company has six months to correct the device in adherence to corrective guidelines given by TÜV SÜD. This is the second suspension from TÜV SÜD.
TÜV SÜD reinstated the CE certificate for Getinge’s subsidiary Datascope Corp. for the Cardiosave Intra-Aortic Pump in July of 2023. This occurred after approximately three months of suspension due to gaps in compliance with applicable regulations.
These conditions must be fulfilled to maintain the CE certificate, it is also mandatory for Cardosave deliveries in countries that require the CE certification.
TÜV SÜD’s evaluation found that Getinge partially fulfilled compliance conditions for the certification. The request to meet conditions causes Getinge to accelerate the implementation of committed product improvements and field safety actions for Cardiosave.
During the six-month suspension, Getinge will not be able to provide intra-aortic balloon pumps to customers that require the CE certificate, representing approximately 100 MSEK of annual Cardiosave sales.
The decision made by TÜV SÜD does not affect Cardiosave’s installed base. Products already on the market can continue to be used and devices in distribution can be delivered. Catheters and spare parts are not affected by TÜV SÜD’s decision.
“We are aware of the very problematic situation this suspension puts on healthcare providers and critically ill patients. Therefore, in close dialogue with TÜV SÜD, we are working urgently to minimize the impact. All affected customers will receive continuous information from us,” Elin Frostehav, President Acute Care Therapies at Getinge told the press.
Getinge is working towards regaining the CE certificate as well as accelerating the development of the next product generation.
TÜV SÜD reinstated the CE certificate for Getinge’s subsidiary Datascope Corp. for the Cardiosave Intra-Aortic Pump in July of 2023. This occurred after approximately three months of suspension due to gaps in compliance with applicable regulations.
These conditions must be fulfilled to maintain the CE certificate, it is also mandatory for Cardosave deliveries in countries that require the CE certification.
TÜV SÜD’s evaluation found that Getinge partially fulfilled compliance conditions for the certification. The request to meet conditions causes Getinge to accelerate the implementation of committed product improvements and field safety actions for Cardiosave.
During the six-month suspension, Getinge will not be able to provide intra-aortic balloon pumps to customers that require the CE certificate, representing approximately 100 MSEK of annual Cardiosave sales.
The decision made by TÜV SÜD does not affect Cardiosave’s installed base. Products already on the market can continue to be used and devices in distribution can be delivered. Catheters and spare parts are not affected by TÜV SÜD’s decision.
“We are aware of the very problematic situation this suspension puts on healthcare providers and critically ill patients. Therefore, in close dialogue with TÜV SÜD, we are working urgently to minimize the impact. All affected customers will receive continuous information from us,” Elin Frostehav, President Acute Care Therapies at Getinge told the press.
Getinge is working towards regaining the CE certificate as well as accelerating the development of the next product generation.