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The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The Intera 3000 Hepatic Artery Infusion Pump is used to continuously deliver medicine through an artery that supplies blood and oxygen to the liver and several other organs (hepatic artery). The pump is implanted into adult patients and delivers chemotherapy medications to treat liver tumors. People with the Intera 3000 Hepatic Artery Infusion Pump are able to get back to daily activities and return to the hospital for pump refills every two weeks.
Intera Oncology is recalling the Intera 3000 Hepatic Artery Infusion Pump after receiving reports from clinicians that the pumps were delivering medications (flow rate) faster than expected.
If the pump delivers infusions at faster than expected flow rates, the patient may receive too much medication at one time, resulting in life-threatening hematologic (myelosuppression) toxicity, neurotoxicity, or death. Additionally, if the flow rate is too fast, the patient may run out of medication before a pump refill occurs, which may allow their disease to progress or lead to death.
There have been three incidents reported related to this issue, with no injuries or deaths.
On July 10, 2022, Intera Oncology sent a letter, emailed, or called customers and requested the following actions:
Customers with questions or concerns about this recall should contact Intera Oncology at (800) 660-2660 or support@interaoncology.com with questions.
Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.