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.
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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.
The US FDA says a recall of Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps is high-risk class I because the devices’ battery packs could fail. This isn’t the first time the pumps have been recalled because of battery troubles.
News We’re Watching – LivaNova And Medtronic Recalls; Approvals For Abbott And Guardant; Pediatric Device Grants
Recalls on a life-support device used during heart surgery and dialysis tubing were announced this week, as were approvals for a breast cancer companion diagnostic and two cardiac ablation catheters. Additionally, the US FDA has grants available for groups that assist in pediatric device development.