Getinge Cardiosave CS100 (Image from Getinge)
Shares of Getinge (STO:GETI-B) dropped 5% today on news that the FDA had received 60 more reports of adverse events — including two deaths and one serious injury — related to the company’s Maquet/Datascope intraortic balloon pumps (IABP).
The FDA said the new reports have come in since it issued a letter in November 2018 alerting healthcare providers to battery problems with the devices. Getinge recalled 22,853 Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i IABP devices due to reports of faulty batteries in May 2019. The FDA declared it a Class I recall in July, saying that the company had reported five patient deaths potentially related to the IABP devices since 2016. The two additional deaths announced today were included in the five reported in July, the agency noted.
