FDA Medical devices recall ·
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H… recall
- Recall number
- Z-2580-2026
- Date
- (initiated May 11, 2026)
- Company / brand
- Boston Scientific Corporation
1 Scimed Pl, Maple Grove, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 1 device
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Why was it recalled?
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN 00850014110147, Serial Number 20175
Distribution
US Nationwide distribution in the state of OH.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2580-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.