FDA Device recall Z-2580-2026
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
- FDA Device
- Class II
- completed
- Published 2026-07-01
On 2026-07-01 the FDA classified a Class II recall of Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device by Boston Scientific, citing there is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2580-2026 |
| Classification | Class II |
| Status | completed |
| Initiated | 2026-05-11 |
| Published | 2026-07-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Reason
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Identifiers
| code_info | GTIN 00850014110147, Serial Number 20175 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: completed.
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FDA Device · Class II · 2026-09-09 · Boston Scientific
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2580-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.