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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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.
- Affected units
- 50
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
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