FDA (Devices) recall action 81055
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.
The agency’s own wording, quoted from the enforcement report.
Maquet Datascope is recalling Cardiosave Hybrid IABP devices due to a potential inability to start therapy for users at altitudes above 3,200 feet.
Maquet Datascope is recalling Cardiosave Rescue IABP devices due to a potential inability to start therapy at altitudes above 3,200 feet.