Class 1 Device Recall Intera 3000 Hepatic Artery Infusion Pump

• Date Initiated by Firm: July 10, 2022
• Date Posted: August 22, 2022
• Recall Status: Terminated on September 12, 2023
• Recall Number: Z-1522-2022
• Recall Event ID: 90642
• PMA Number: P890055
• Product Classification: Pump, infusion, implanted, programmable - Product Code LKK
• Product: INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
• Code Information: UDI-DI: 00850014110147; Catalogue No. AP03000H; Serial No. 16145, 16151, 16154, 16171, 16177, 16179, 16196, 16201, 16204, 16211, 16212, 16219, 16220, 16235, 16244, 16247, 16260, 16270, 16273, 16298, 16304, 16309, 16313, 16319, 16338, 16346, 16354, 16376, 16379, 16389, 16393, 16394, 16395,16402, 16403, 16405, 16408, 16409, 16411, 16425, 16426, 16428, 16433, 16434, 16437, 16450, 16459, 16461, 16464, 16485.
• Recalling Firm/ Manufacturer: Intera Oncology, Inc.; 65 William St; Wellesley MA 02481-3802
• For Additional Information Contact: Michael Gaisford; 917-331-4503
• Manufacturer Reason for Recall: Higher than expected flow rate.
• FDA Determined Cause: Process design
• Action: Customers were notified by a combination of letter, call, and/or email of this recall on July 10, 2022. Customers were informed via notification that Intera 3000 Hepatic Artery Infusion Pumps are being recalled due to complaints reporting higher-than-expected flow rates. Customers are asked to secure affected pumps in inventory to ensure they are not implanted and to contact Intera Oncology at 1-800-660-2660 to arrange return of product. Intera requests physicians continue to monitor the pump flow rate per standard refill procedure, and continue to monitor for liver toxicity to adjust dosing as per standard protocols.
• Quantity in Commerce: 50 units
• Distribution: US distribution to states of: AL, CA, IL, KY, MN, MO, NC, NJ, NY, OH, OR, PA, & TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LKK