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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.

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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

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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.

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