FDA Offers Update on Intera Oncology’s Infusion Pump Recall

The FDA has issued an update on Intera Oncology’s July 10 recall of its Intera 3000 Hepatic Artery Infusion Pumps, deeming it a Class 1 recall because of the risk of serious injury and death.

The implanted pump is designed to continuously deliver medicine through an artery that supplies blood and oxygen to the liver or other organs. It can be used to deliver chemotherapy to treat liver tumors.

The recall was prompted by reports from clinicians that the pumps were delivering medications faster than expected, which could lead to possible life-threatening toxicity. There is also a risk of running out of medication before a pump refill occurs, which could lead to disease progression or death, the agency said.

The 440 affected products were distributed from Aug. 12, 2021 to May 17. Three incidents have been reported, but there have been no reports of injuries or deaths related to this issue so far, the FDA said.