腾讯网

上万台，这一设备今年4次I级召回

日前，外媒报道，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）再度被FDA标记为最严重的I级召回，使用这些设备可能会导致严重伤害或死亡。
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 ...
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 ...
Medscape

FDA Expands List of Getinge IABP System and Component Shortages

The US Food and Drug Administration (FDA) today issued a letter to healthcare providers describing a current shortage of Getinge intra-aortic balloon pump (IABP) catheters and other components.
TCTMD

MAQUET Cardiovascular Announces FDA 510(k) Clearance and CE Mark for the Cardiosave Intra ...

Mahwah, NJ-- MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, announced U.S. Food & Drug Administration (FDA) 510(k) clearance and CE mark today at the 2011 Transcatheter ...