Recall Ledger

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall (Boston Scientific Corporation)

Medical deviceClass IICompleted

Summary: Boston Scientific Corporation is recalling 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.

What is being recalled

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

Why

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

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide distribution in the state of OH.

How to tell if yours is affected

GTIN 00850014110147, Serial Number 20175

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2580-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusCompleted
Recall startedMay 11, 2026
ReportedJuly 1, 2026
CompanyBoston Scientific Corporation
Company locationMaple Grove, MN, United States
Initiated byVoluntary: Firm initiated
Quantity1 device

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Official FDA record