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 ...
TCTMD

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

Another week, another recall for the beleaguered Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs) manufactured by Getinge/Datascope—this time due to a “communication loss” ...
Medscape

Another FDA Class I Recall of Cardiosave Hybrid/Rescue IABPs

Datascope/Getinge is recalling certain Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) because the coiled cable connecting the display and base on some units may fail, ...
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 ...
Becker's Hospital Review

Recalled heart device tied to 1 death, 4 serious injuries, FDA says

The FDA on Jan. 25 announced a class 1 recall of Datascope/Getinge’s Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump after one death and four serious injuries were reported. A class 1 recall ...
Business Wire

MAQUET Medical Systems USA Showcases CARDIOSAVE®™ IABP HYBRID & RESCUE at National Event Committed to Healthcare Innovation

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 ...
Healio

FDA designates recall of two intra-aortic balloon pumps as class I

Please provide your email address to receive an email when new articles are posted on . Datascope/Maquet/Getinge intra-aortic balloon pumps recalled due to risk for unexpected shutdown. The FDA has ...
Becker's Hospital Review

Heart balloon pumps added to medical device shortage list

The FDA placed some balloon pumps on its medical device shortage list Dec. 2, which the agency said was because of increased demand and shortage of some of the product’s components. There is a ...
Yahoo Finance

UPDATE 2-US FDA advises healthcare facilities to switch from Getinge's heart devices

May 8 (Reuters) - The U.S Food and Drug Administration (FDA) on Wednesday advised healthcare facilities to move away from using Getinge's heart devices in patients as they faced safety and quality ...
Finanznachrichten

Getinge AB: EU CE-Mark Reinstated for Cardiosave Intra-Aortic Balloon Pump

Today, Getinge announces that the EU Notified Body TÜV SÜD has reinstated the EU CE Mark for Getinge's Cardiosave Intra-Aortic Balloon Pump (through the issuance of an updated EU Medical Device ...
Healio

FDA designates intra-aortic balloon pump recall as class I

Please provide your email address to receive an email when new articles are posted on . The FDA announced it has designated a recall of intra-aortic balloon pumps by Datascope/Getinge as class I, the ...