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

FDA device recall Z-2580-2026 · posted 2026-06-25 · Completed

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

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

Action taken

Boston Scientific issued an Urgent Medical Device Removal - Immediate Action Required notice to it sole consignee on 5/11/2026 via hand delivery. The notice explained the issue and requested the following: "Instructions: " Immediately stop further use of this specific Intera HAI Pump (S/N 20175). " A Boston Scientific representative will retrieve the impacted device and process the return. " Complete and return the enclosed Reply Verification Tracking Form per the included instructions. " Report any adverse events or quality concerns associated with the use of this device to Boston Scientific via email at HAI-quality@bsci.com or FDA s MedWatch Adverse Event Reporting program [www.fda.gov/MedWatch/report.htm or 1.800.FDA.1088 (332.1088)]." The unit was collected by a representative of the firm and subsequently destroyed.

Root cause

Process control

Status

Completed

Product code

LKK

Quantity affected

1 device

Distribution

US Nationwide distribution in the state of OH.

Date initiated

2026-05-11

Date posted

2026-06-25

Location

Maple Grove, MN