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, ...
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” ...
Yahoo Finance

FDA tells providers to stop using Getinge heart devices

The Food and Drug Administration in a letter Wednesday told healthcare providers and facilities they should stop using certain Getinge cardiovascular medical devices. Getinge has initiated 20 recalls ...
TCTMD

Cardiosave IABPs—Yet Again—the Subject of a Class I Recall: FDA

Yet another recall—the second in the space of a week—has been announced by the Food and Drug Administration for the Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs). And yet ...
FierceBiotech

Amid CE mark suspension, Getinge cardiac balloon pumps hit with 2nd Class I recall this year

Just a week after Getinge temporarily lost CE mark clearance in Europe for its Cardiosave intra-aortic balloon pumps, the FDA has handed down a Class I recall rating to the devices—the second such ...
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 ...
RAPS

Five Deaths Reported Prior to Recall of Intra-aortic Balloon Pumps

The US Food and Drug Administration (FDA) on Tuesday designated Getinge’s Maquet/Datascope recall of intra-aortic balloon pumps (IABPs) as Class I after five patient deaths were reported since 2016.
Yahoo Finance

FDA issues warning on Getinge device amid quality concerns

The US Food and Drug Administration (FDA) has urged healthcare providers not to use certain Getinge devices amid concerns that the company’s devices still pose a risk to users despite a previous ...
FierceBiotech

Getinge heart balloon pumps further deflated by 4 more Class I recalls and 6 reported patient deaths

In a flurry of Aug. 31 notices from the FDA, the number of Class I recalls plaguing Getinge’s Cardiosave intra-aortic balloon pumps this year has doubled. The notices detailed four more recalls of the ...
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 ...
Medscape

FDA Class I Recall of CardioSave Hybrid/Rescue IABPs

Datascope/Getinge/Maquet is recalling CardioSave Hybrid and Rescue intra-aortic balloon pumps (IABP) because some battery packs may have a shortened run-time and fail unexpectedly, according to a ...
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 ...