Class II — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Completed |
| Reason | There is the potential for leakage along the drug pathway from the pump through the end of the catheter. |
| Product | Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device |
| Quantity | 1 device |
| Distribution | US Nationwide distribution in the state of OH. |
| Initiated | 2026-05-11 |
| Classified | 2026-06-25 |
| Recall number | Z-2580-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Boston Scientific Corporation (Z-2580-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99063/
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