A software correction is currently being developed to address its inability to start therapy for patients at altitudes above 3200 feet.
Not sure what’s been recalled, withdrawn from the market, or had safety updates? Catch up on the US Food and Drug Administration’s (FDA’s) recalls and market withdrawals from this past week.
Gettinge is issuing a worldwide recall of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp due to the IABP’s potential interruption and/or inability to start therapy for patients at altitudes above 3200 feet (975 m).
A software correction is currently being developed by Maquet/Getinge to address the altitudes issue, which is anticipated to commence installation in February 2019.
To date, no adverse events have been reported to date, and CS100 or CS300 IABPs used in IABs are not affected by this issue.
For more information on this recall, check out the FDA’s statement.
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