The FDA and Intera Oncology recalled a hepatic artery infusion pump after reports from clinicians indicated the device was delivering medications at a faster-than-expected rate, an FDA news release stated July 10.
The Intera 3000 hepatic artery infusion pump delivers continuous medication through an artery to the liver and several other organs. The device was designed to deliver chemotherapy medications to patients with liver tumors.
Over-delivering medication can result in life-threatening hematologic toxicity, neurotoxicity or death.
Three incidents were reported of this issue with no injuries or deaths; however, the FDA has identified this as a Class I recall, the most serious type of recall, due to risk of death.