Intera Oncology Recalls Intera 3000 Hepatic Artery Infusion Pump Because of Faster-Than-Expected Flow Rates

August 30, 2022

On August 29, 2022, the U.S. Food and Drug Administration (FDA) reported (https://www.fda.gov/medical-devices/medical-device-recalls/intera-oncology-recalls-intera-3000-hepatic-artery-infusion-pump-due-faster-expected-flow-rates-may?utm_medium=email&utm_source=govdelivery) Intera Oncology’s recall of the Intera 3000 hepatic artery infusion pump because of reports that the devices were delivering medications faster than expected. FDA identified it as a class I recall, the most serious type of recall, where use of the device may cause serious injuries or death.

Intera Oncology Recalls Intera 3000 Hepatic Artery Infusion Pump Because of Faster-Than-Expected Flow Rates

Intera Oncology received three reports about the delivery defect, none of which were associated with injuries or death. The recall affects 440 devices distributed from August 12, 2021–May 17, 2022. For a list of recalled product codes, see FDA’s medical device database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=195297).

FDA explained that if the pump delivers medication faster than expected, a patient can receive an excessive amount, resulting in life-threatening hematologic toxicity (i.e., myelosuppression), neurotoxicity, or death. Additionally, the medication can run out before the pump refills, which may lead to disease progression or death.

Intera Oncology sent a notice to customers in July 2022 and recommended the following actions:

Intera Oncology also suggested that the hepatic artery infusion therapy care team decide whether to inform patients about the possibility of flow alterations.

Customers with questions about the recall can contact Intera Oncology at 800-660-2660 or support@interaoncology.com (mailto:support@interaoncology.com).

Healthcare professionals and consumers should report any adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.


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