FDAFDA recall Z-2580-2026 · Jul 1, 2026
Boston Scientific Corporation: Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall
Recall found
Product
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Reason for recall
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Completed
- Codes, lots and dates
- GTIN 00850014110147, Serial Number 20175
- Quantity
- 1 device
- Distribution
- US Nationwide distribution in the state of OH.
- Recalling firm
- Boston Scientific Corporation, Maple Grove, MN
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-11
Source: openFDA enforcement record Z-2580-2026 · search recall number Z-2580-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.