← FDA ENFORCEMENT
Z-2580-2026Class II

Boston Scientific Corporation

Recalling firm
Boston Scientific Corporation
Product type
Device
Status
Completed
Report date
2026-07-01
Distribution
US Nationwide distribution in the state of OH.
Firm state
MN
Product quantity
1 device
Initiated by
Voluntary: Firm initiated
Reason for recall

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

Product description

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device

Code / lot info

GTIN 00850014110147, Serial Number 20175

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.