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The company has been given three months to adhere to the required corrective actions.
March 27, 2023
By: Charlie Sternberg
TÜV SÜD, a notified body for certification services, has suspended the CE-certificate for Getinge’s Intra-Aortic Balloon pump Cardiosave, effective immediately. The company has been given three months to adhere to the required corrective actions, during which time Getinge will not be able to provide balloon-pumps to customers requiring a CE certificate. The suspension is based on concerns related to risk management, post market surveillance and vigilance, as well as information pertaining to timeliness of field safety corrective actions. This suspension affects SEK 70 M of the annual sales of Cardiosave Intra-Aortic Balloon pumps. However, pumps already on the market can continue to be used and devices already in distribution can be delivered. Balloons and spare parts are not affected. “Getinge is aware of the severe situation this suspension puts on healthcare providers and critically ill patients,” the company stated. Getinge is in dialogue with TÜV SÜD, and all affected customers will receive communication from Getinge. At present, the financial impact is not expected to be material.
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