The U.S. Food and Drug Administration (FDA) classified the recall of Getinge’s (OTCPK:GNGBF) (OTCPK:GNGBY) heart devices as the agency’s Class 1 recall, the most serious type of recall as their use may cause serious injuries or death.
Datascope, a unit of Swedish medical device maker Getinge, is recalling Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP).
The FDA said that these products are being recalled because a compromised intra-aortic balloon (burst, leaking or torn balloon) can cause blood to enter the IABP during therapy (a blood back event).
The FDA said the distribution dates for the product March 6, 2012 to present. Recall was started on Dec. 19, 2022.
The FDA noted that blood in the pump can cause several issues, including unexpected pump shutdown if blood contacts electrical components; patients may have helium released into their blood and these helium gas bubbles can damage organs; and patient’s blood loss.
In addition, if affected IABP is not evaluated before use with a new patient, that patient may be exposed to cross-contaminated blood and may cause life-long bacterial and viral disease; and maintenance personnel may be exposed to a biohazard if proper containment precautions are not be taken, according to the agency.
The FDA said that Getinge has reported 134 complaints about this issue, including 12 device shutdowns and 5 adverse events, which include 4 serious injuries and 1 death.
On Dec. 19, 2022, Datascope/Getinge sent customers an urgent medical device recall letter which provided certain guidelines and user actions.