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Regulatory Focus™ > News Articles > 2019 > 7 > Five Deaths Reported Prior to Recall of Intra-aortic Balloon Pumps

Five Deaths Reported Prior to Recall of Intra-aortic Balloon Pumps

Posted 24 July 2019 | By Ana Mulero 

Five Deaths Reported Prior to Recall of Intra-aortic Balloon Pumps

The US Food and Drug Administration (FDA) on Tuesday designated Getinge’s Maquet/Datascope recall of intra-aortic balloon pumps (IABPs) as Class I after five patient deaths were reported since 2016.
 
The recall seeks to address an issue with the IABPs shutting down during patient use or failing to initiate therapy due to battery failures. Affected modes include all lot numbers of the Cardiosave Hybrid IABPs Cardiosave Rescue IABPs, CS300 IABPs and CS100/100i IABPs.
 
In its notice on the recalls, FDA repeats Maquet/Datascope’s explanation of what caused the reported battery failures. “If battery maintenance is not performed per the Operating Instructions Manual for each IABP, the battery may provide less than the expected minimum run time of operating power per battery.” FDA and the firm offer recommendations for using the affected models pending the software upgrades, such as ensuring IABPs are plugged into AC power outlets whenever possible.
 
The Class I designation brings awareness to the 22,853 devices recalled in the US, though Maquet/Datascope began recalling all affected models on a global scale since May.
 
“The reason for the recall is to help Getinge’s customers avoid battery shut down by ensuring all IABP users follow each device's Operating Instructions Manual for recommendations on usage, charging, maintenance and storage of the batteries,” the firm reports to its IABP customers.
 
FDA and the firm were made aware of the five patient deaths—two for CS300, two for CS100 and one for Cardiosave—between March 2016 through May 2017. Yet the firm has not concluded that the reported deaths “are due solely to the device shutting down while operating on battery power.”
 
Maquet/Datascope intends to release a Cardiosave battery maintenance software upgrade by early 2020. The firm reportedly released a similar upgrade for both CS300 and CS100 in 2017.
 
The last time FDA designated a Maquet/Datascope recall of the Cardiosave Hybrid IABP as Class I was in November 2018 when it instructed customers to use the CS100 IABP or CS300 IABP as alternatives to the Cardiosave Hybrid and Rescue IABP models. CS100i, CS100 and CS300 were also subjected to a Class I recall in October 2017. Similar adverse events were cited when CS300 and CS100/100i were subjected to Class I recalls in 2011 and 2014. 
 
Recalls have not been the only troubles facing the Getinge subsidiaries. Datascope drew an FDA warning letter in February over violations of good manufacturing practices, including failure to perform design validation for the Cardiosave device and failure to verify whether corrective actions implemented to address battery failures associated with CS100, CS100i and CS300 IABPs were effective. A warning letter issued to Datascope last October cited similar violations.
 
FDA
 

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