FDA DevicesClass II
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable ...
Published: July 1, 2026Recall ID: Z-2580-2026Category: devicesCountry: US
Reason for Recall / Hazard
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Product Description & Identification
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Additional Source Details
| Field | Value |
|---|---|
| City | Maple Grove |
| State | MN |
| Event id | 99063 |
| Address 1 | 1 Scimed Pl |
| Address 2 | N/A |
| Code info | GTIN 00850014110147, Serial Number 20175 |
| Postal code | 55311-1565 |
| Report date | 20260701 |
| Product type | Devices |
| Product quantity | 1 device |
| Reason for recall | There is the potential for leakage along the drug pathway from the pump through the end of the catheter. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260511 |
| Initial firm notification | Visit |
| Center classification date | 20260625 |
Overview
- Recalling FirmBoston Scientific Corporation
- StatusCompleted
- Risk LevelClass II
- DistributionUS Nationwide distribution in the state of OH.