Boston Scientific Corporation: Pump, Infusion, Implanted, Programmable

Recall Summary Boston Scientific is recalling the INTERA 3000 Hepatic Artery Infusion Pump, an implanted drug delivery device, because medication could leak from the pump through the catheter. The device was distributed nationwide. Patients who have this pump implanted should contact their healthcare provider or Boston Scientific for more information.

Recalling firm
Boston Scientific Corporation
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.
Classification
Class III
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-05-11
Status
Completed
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide distribution in the state of OH.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/35d288f0-c48b-4ad4-91c0-8c7f81ada3a9