INTERA 3000 implantable pump recalled for higher-than-expected flow rate
The FDA is recalling INTERA 3000 implantable hepatic infusion pumps due to a malfunction causing higher-than-expected medication flow rates. Patients should contact their healthcare provider.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I recall of an implantable medical device with a malfunction affecting critical medication delivery. Class I classification indicates reasonable probability of serious adverse health consequences or death. The potential for serious harm from incorrect chemotherapy dosing warrants the highest severity classification.
Plain-English summary
The FDA is recalling INTERA 3000 Hepatic Artery Infusion Pumps (30 mL, Rx Only, sterile, implantable) due to a malfunction causing higher-than-expected flow rates. This is a Class I recall, the FDA's most serious classification.
Approximately 50 units were distributed to patients in 13 U.S. states: Alabama, California, Illinois, Kentucky, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, and Texas. The specific serial numbers of affected units have been identified by the manufacturer.
Patients with implanted INTERA 3000 pumps should contact their healthcare provider immediately to verify the serial number of their device and assess pump function. Healthcare providers should check the affected serial number list provided in the official FDA recall notice. No illnesses or injuries have been reported to the FDA in connection with this defect.
Manufacturer Intera Oncology, Inc., is coordinating with healthcare providers and patients on this recall.
The recalled product
- Product
- INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
- Manufacturer
- Intera Oncology, Inc.
- Hazard
- incorrect-flow-rate
- overdose-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed in 13 states:
- AL
- CA
- IL
- KY
- MN
- MO
- NC
- NJ
- NY
- OH
- OR
- PA
- TX
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