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

Class II
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.
Affected products (lot / model / serial)
GTIN 00850014110147, Serial Number 20175
Units affected
1 device
Distribution pattern
US Nationwide distribution in the state of OH.
Firm location
Maple Grove, MN, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Visit
Product type
Devices
Status
Completed
Recall number
Z-2580-2026
Recall initiated
May 11, 2026
FDA classification date
June 25, 2026
FDA report date
July 1, 2026
FDA event ID
99063
Last updated on HTM Vibe
July 23, 2026
View on openFDA