FDA Class I Recall for Getinge Cardiohelp Emergency Drive
The drive may become stuck or hard to turn, raising the possibility that the patient may not receive adequate hemodynamic support or gas exchange.
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The drive may become stuck or hard to turn, raising the possibility that the patient may not receive adequate hemodynamic support or gas exchange.
The FDA has announced that Datascope/Maquet/Getinge is recalling the Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) because they may shutdown unexpectedly due to electrical failures in the Power Management Board and/or Solenoid Board (Power Source Path).
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
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
The intra-aortic balloon umps (IABP) were recalled for risk that blood may pump through damaged balloon catheter, causing patient harm