Recall Z-2580-2026 ยท LKK Pump, Infusion, Implanted, Programmable
Boston Scientific Corporation
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
| Date | Jun 25, 2026 (initiated May 11, 2026) |
| Status | Completed |
| Reason | There is the potential for leakage along the drug pathway from the pump through the end of the catheter. |
| Root cause | Process control |
| Action | Boston Scientific issued an Urgent Medical Device Removal - Immediate Action Required notice to it sole consignee on 5/11/2026 via hand delivery. The notice explained the issue and requested the following: "Instructions: " Immediately stop further use of this specific Intera HAI Pump (S/N 20175). " A Boston Scientific representative will retrieve the impacted device and process the return. " Complete and return the enclosed Reply Verification Tracking Form per the included instructions. " Report any adverse events or quality concerns associated with the use of this device to Boston Scie |
| Quantity | 1 device |
| Distribution | US Nationwide distribution in the state of OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.