FDA issues warning on Getinge device amid quality concerns [Yahoo! Finance]
GETINGE AB UNSP/ADR (GNGBY)
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Source: Yahoo! Finance
In a statement published on 8 May, the FDA urged healthcare providers to move away from using the Cardiosave Hybrid and Rescue intra-aortic balloon pump (IABP) by Swedish company Datascope, as it continues to receive reports of concern following a recall. It is also warning clinicians to move away from Getinge's cardiopulmonary bypass (CPB) devices, including the Getinge Cardiohelp system and HLS Sets. The FDA says that over the last 12 months, the FDA has received 2,964 medical device reports (MDR) related to Cardiosave IABPs, of those, 15 were reported as resulting in patient serious injury or death. From 1 January 2023, Getinge has initiated 12 voluntary recalls in the US for the Cardiosave IABP. The FDA classified eight as a Class I recall - the most serious type of recall. Since then, the authority has continued to receive reports of concern. The FDA said that some of the reports describe Cardiosave IABP devices shutting down, it has also been evaluating other concerns wit
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News
- Getinge limits sale of heart devices in the US after FDA warning [Reuters]Reuters
- Getinge's financial target 2024-2028: Adjusted EPS growth of above 12% on average [Yahoo! Finance]Yahoo! Finance
- FDA Roundup: May 10, 2024 [Yahoo! Finance]Yahoo! Finance
- US FDA recommends healthcare providers switch from Getinge's heart devices [Reuters]Reuters
- Medical gear maker Getinge's Q1 core profit beats expectations [Reuters]Reuters