FDA recall, , Moderate risk
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump
The Intera Oncology Intera 3000 Hepatic Artery Infusion Pump has potential for leakage along the drug pathway.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Corporation of Maple Grove, Minnesota, recalled one Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, model AP-0300H, an implantable drug delivery device, because of the potential for leakage along the drug pathway from the pump through the end of the catheter. The company began the recall on May 11, 2026, and the FDA added it to its Enforcement Report on June 25, 2026.
The recalled device was distributed in Ohio as part of nationwide distribution in the state. The FDA classified the recall on June 25, 2026, and included it in the weekly enforcement report on July 1, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
- UDI-DI
- 00850014110147
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Ohio.
- Company
- Boston Scientific CorporationMaple Grove, Minnesota
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99063
- Recall number
- Z-2580-2026
- Quantity recalled
- 1 device
All recalls from Boston Scientific Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
