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Another FDA Class I Recall of Cardiosave Hybrid/Rescue IABPs

The coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown, without warnings or alarms to alert the user, the FDA says. ....

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Datascope/Getinge Recalls Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown After Coiled Cord Connection Failure

Datascope, a subsidiary of Getinge, is recalling Cardiosave Hybrid IABPs and Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown ....

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Second Recall in Less Than 2 Months for Cardiosave IABPs

In a Class I recall notice, the FDA says a coiled cable that connects the display and the base may fail, causing the IABP to shut down. ....

Datascope Getinge , Getinge Datascope , Drug Administration , Cardiosave Hybrid , Cardiosave Rescue ,

FDA designates intra-aortic balloon pump recall as class I

The FDA announced it has designated a recall of intra-aortic balloon pumps by Datascope/Getinge as class I, the most serious kind.The recall occurred because the coiled cable connecting the display and the base might fail in some units of the intra-aortic balloon pumps (IABPs; Cardiosave Hybrid and Cardiosave Rescue), causing the unit to shut down without warning, according to an alert issued by ....

Richard Smith , Datascope Getinge , Cardiosave Hybrid , Cardiosave Rescue ,

New IABP Recall: Balloon Catheter Damage Might Cause Bleeding Into Pump

This is the latest in a long string of recalls for the Getinge/Datascope Cardiosave Hybrid and Rescue IABPs. ....

Getinge Datascope , Drug Administration , Cardiosave Hybrid , Cardiosave Rescue , Urgent Medical Device Recall ,