INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile… recallZ-1522-2022 · Intera Oncology, Inc. · initiated Jul 10, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Intera Oncology, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Higher than expected flow rate.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-1522-2022
- Status
- Terminated
- Initiated by the company
- Jul 10, 2022
- Posted by the FDA
- Aug 22, 2022
- Recalling firm
- Intera Oncology, Inc.
- Quantity
- 50 units
- Product code
- LKK
- FDA submissions
- P890055
- Distribution
- US distribution to states of: AL, CA, IL, KY, MN, MO, NC, NJ, NY, OH, OR, PA, & TX.
Product description
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- INTERA AP-03000HIntera Oncology Inc. · Pump, Infusion, Implanted, Programmable2 recalls274 reports
Other devices under the same FDA submission
6 devices cleared under P890055 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- CODMAN AP-03000HCerenovus, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 deaths32 reports
- CODMAN AP-03000LCerenovus, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE17 reports
- NA IP-37957Medos International Sàrl · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE6 reports
- CODMAN AP-03000MCerenovus, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE3 reports
- MEDSTREAM 91-4201USCerenovus, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE3 reports
- CODMAN AP-03000ULCerenovus, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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