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” ...
TCTMD

MAQUET Cardiovascular Announces FDA 510(k) Clearance and CE Mark for the Cardiosave Intra-Aortic Balloon Pump

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 ...
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 ...
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, ...
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 ...
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 ...
Becker's Hospital Review

Getinge recalls intra-aortic balloon pumps over fluid leaks

Getinge is recalling 4,338 intra-aortic balloon pumps after discovering fluid leaks that can lead to unexpected shutdowns or the inability to initiate therapy, the FDA said Dec. 16. The agency 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

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 ...
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 ...
Medscape

Another FDA Class I Recall of Cardiosave Hybrid/Rescue IABPs

Datascope/Maquet/Getinge has announced a recall of the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) because they may shut down unexpectedly due to electrical failures in the power ...
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 ...