Z-2580-2026Class II

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

Name: Z-2580-2026 Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Creator: Boston Scientific Corporation
Published: 2026-05-11
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2026-05-11 / Completed / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device on 2026-05-11. FDA classified it as Class II and gives the reason as "There is the potential for leakage along the drug pathway from the pump through the end of the catheter". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2580-2026
Classification: Class II
Status: Completed
Initiated: 2026-05-11
Posted: 2026-06-25
Recalling firm: Boston Scientific Corporation
Product: Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected] 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.
Quantity in commerce: 1 device
Distribution: US Nationwide distribution in the state of OH.
Product codes and lots: GTIN 00850014110147, Serial Number 20175

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2580-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2580-2026	Class II	Completed	Voluntary: Firm initiated	2026-07-01	2026-06-25

Product code LKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)