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U.S. Department of Health and Human Services

Class 1 Device Recall Intera 3000 Hepatic Artery Infusion Pump

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  Class 1 Device Recall Intera 3000 Hepatic Artery Infusion Pump see related information
Date Initiated by Firm July 10, 2022
Date Posted August 22, 2022
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = Intera Oncology
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