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Datascope/Getinge Issues New Recall of Certain Cardiosave Hybrid and Rescue IABPs for Risk of Unexpected Shutdown

According to a new release issued by the U.S. Food and Drug Administration (FDA), Datascope, a subsidiary of Getinge, is recalling Cardiosave Hybrid IABPs and Rescue IABPs because a communication loss between the executive processor printed circuit board assembly (PCBA) and the video generator PCBA may cause an unexpected shutdown

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Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

The latest Class I recall for these beleaguered devices relates to communication loss between circuit board assembly units.

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Getinge s Datascope has its second Class I recall in a month

The FDA issued a notice determining another recall of Getinge subsidiary Datascope’s Cardiosave IABPs as Class I, the most serious kind.

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Getinge s Datascope has another serious aortic balloon pump recall

The FDA issued a notice determining a recall of Getinge subsidiary Datascope's Cardiosave IABPs as Class I, the most serious kind.

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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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