Another Class I Recall For Datascope’s Aortic Balloon Pumps
Datascope/Getinge has initiated another recall of its Intra-Aortic Balloon Pumps, this time for a potentially faulty cable connection.
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Total Recall: Datascope/Getinge Gets Another Class I Recall For Its Aortic Balloon Pumps
Datascope/Getinge has initiated yet another recall of its Intra-Aortic Balloon Pumps, this time because of a communication loss between the circuit board and video generator. The FDA has given this recall a class I designation.
Class I Recall Of Datascope Cardiac Assist Devices
The US Food and Drug Administration has designated a recall of Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps from Datascope/Getinge as class I due to the potential for the pumps to shut down during use.
Class I Recall Announced On Cardiosave Cardiac Assist Devices After Patient Death
The recall, which is related to the risk fluid leaks may make the pumps shut down during use, comes only a few months after battery packs used in the pumps were recalled.