Z-1522-2022Class I

INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump

Name: Z-1522-2022 INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump
Creator: Intera Oncology, Inc.
Published: 2022-07-10
License: https://open.fda.gov/license/

Intera Oncology / initiated 2022-07-10 / Terminated / root cause: manufacturing process

FDA source

Intera Oncology, Inc. began a recall of INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump on 2022-07-10. FDA classified it as Class I and gives the reason as "Higher than expected flow rate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1522-2022
Classification: Class I
Status: Terminated
Initiated: 2022-07-10
Posted: 2022-08-22
Terminated: 2023-09-12
Recalling firm: Intera Oncology
Product: INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: Higher than expected flow rate.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1522-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1522-2022	Class I	Terminated	Voluntary: Firm initiated	2022-08-31	2022-08-22

Product code LKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)