Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Summary
The FDA issued a Class II for Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable by Boston Scientific Corporation. Reason: There is the potential for leakage along the drug pathway from the pump through the end of the catheter..
Details
Source
Device Recall
External ID
Z-2580-2026
Action Date
2026-07-01
Status
Completed
Category
device
Product Description
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Lot/Code Info: GTIN 00850014110147, Serial Number 20175
Quantity Affected: 1 device
Reason for Recall
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Distribution
US Nationwide distribution in the state of OH.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-11
Company
Maple Grove, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 286 device recalls issued in the same week, part of 534 device-related FDA actions this month.
Boston Scientific Corporation has 406 FDA actions in our database, including 341 recalls and 65 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 406 FDA actions in our database, including 341 recalls and 65 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2580-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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