Recall Z-2580-2026— Boston Scientific Corporation

Name: FDA recall Z-2580-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-11

Class II · Completed

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2026-05-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device. Reason: There is the potential for leakage along the drug pathway from the pump through the end of the catheter..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Completed
Initiated: 2026-05-11
Firm location: Maple Grove, MN, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.