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.
The agency said today that although the deaths cannot be definitively attributed to the device shutting down, these devices are used on critically ill patients in healthcare facilities, including during transport, and that any interruption in treatment can result in serious patient harm or death. As part of the recall, Maquet/Datascope is contacting each customer to schedule a training visit to review updated battery instructions, use, care and maintenance. The company is now providing a reference guide specific to each IABP based on the operating instructions manual(s) with each device.
The FDA said it is continuing to work with the manufacturer to examine and address the root cause of these IABP devices shutting down while running on battery power. Maquet/Datascope is developing a Cardiosave battery maintenance software upgrade. A similar software upgrade was released for the CS300 and CS100/CS100i in 2017.
“Although the FDA remains concerned about the device shutdown events associated with Maquet/Datascope IABPs, we recognize that these systems may be the best option for circulatory support for some patients,” the agency said.
Getinge did not immediately respond to a request for comment.
Shares in GETI-B were down 4.9% to $160.95 at 1:30 p.m. Eastern time today.