FDA recall Z-2580-2026

Boston Scientific Corporation · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution in the state of OH.

Key facts

Status
Completed
Initiation date
2026-05-11
Report date
2026-07-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2580-2026