Device product
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Z-2580-2026
Product summary
- Event
- Event 99063
- Status
- Completed
- Classification
- Class II
- Quantity
- 1 device
- Official record key
device-enforcement:Z-2580-2026
Official wording
Reason: There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Code information: GTIN 00850014110147, Serial Number 20175
Distribution pattern: US Nationwide distribution in the state of OH.
Derived failure modes
-
Unknown
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.