Recall: Cardiosave Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP)
On 2018-09-20, the FDA announced that Getinge is conducting a recall on Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) due to a possible undetermined hazard. The recalled products were sold under the brand name(s) Cardiosave during an unspecified time period throughout the regions shown in the map below.
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Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP)
Brand Name(s): Cardiosave
Reason for Recall: Potential interruption and/or inability to start therapy to the patient
Official Recall Date: 2018-09-20
Additional information provided by the FDA.gov:
Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability. Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.