Two deaths, one serious injury and more than 60 medical device reports have been linked to Maquet/Datascope's intra-aortic balloon pumps in the past year, the FDA warned healthcare providers in a Nov. 19 letter.
Swedish medical technology company Getinge, which owns Maquet/Datascope, recalled the pumps in July 2019 after receiving reports of battery failures. The devices treat patients undergoing surgery, those with acute coronary syndrome and those with complications from heart failure.
The devices are linked to a range of problems, including failure to hold battery charge, sudden shutdowns and shortened battery run times that could cause the pump to stop working.
The FDA said in November 2018 that the devices had been linked to five patient deaths since 2016. While the FDA said not all of the deaths can be definitively attributed to the devices shutting down, the devices are used on critically ill patients in healthcare facilities, including during transport, and any interruption in treatment can result in serious patient harm or death.
The FDA said in its letter that it wants to make sure healthcare providers are aware that device failures continue to be reported and that the agency remains concerned about shutdowns associated with the devices, but that they may be the best treatment option for some patients.
The FDA said Maquet/Datascope is in the process of developing battery maintenance software upgrades for the devices and the agency is working with the company to determine why the devices may shut down.
The agency added that facilities using the devices should review new reference guides for the devices and schedule training visits.
Read the full letter here.