腾讯网

全球80％份额，巨头这一产品I级召回

近日，FDA对全球感控及外科手术设备巨头Getinge（以下简称“洁定”）子公司Datascope的Cardiosave Hybrid IABP（混合型主动脉内球囊泵）和Cardiosave Rescue IABP（救援主动脉内球囊泵）进行了最严重的I级召回，召回此前十年——2012年3月6日至今生产的IBAP设备，共计8759台。
TCTMD

FDA: Class I Recall for Cardiosave Hybrid IABP Due to ‘Fluid Ingress’

The US Food and Drug Administration (FDA) has alerted users of Datascope Corp/MAQUET’s Cardiosave hybrid intra-aortic balloon pump (IABP) to a “design issue” that enables fluids to leak into the ...
Medscape

FDA Classifies Cardiosave IABP Recall as Class I

Getinge is recalling its Datascope/Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) because of reports of fluid leaks. There has been one death and 71 complaints ...
Business Wire

MAQUET Medical Systems USA Showcases CARDIOSAVE®™ IABP HYBRID & RESCUE at National Event ...

WAYNE, N.J.--(BUSINESS WIRE)--CARDIOSAVE ® IABP HYBRID & RESCUE was one of 14 medical innovations on display in front of thousands of healthcare providers and experts at the Premier healthcare ...
Medscape

FDA Spotlights Woes With Getinge’s Recalled IAB Pumps

The US Food and Drug Administration (FDA) is updating healthcare providers on device failures associated with Getinge’s Maquet/Datascope intra-aortic balloon pumps (IABPs), including the Cardiosave ...