INTERA 3000 Hepatic Artery Infusion Pump — Class I medical device recall Z-1522-2022
Terminated recall by Intera Oncology, Inc., reported 2022-08-31, distributed in AL, CA, IL, KY, MN, MO, NC, NJ…. Higher than expected flow rate.
| Recall number | Z-1522-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intera Oncology, Inc., Wellesley, MA, United States |
| Recall initiated | 2022-07-10 |
| Classified | 2022-08-22 |
| Reported by FDA | 2022-08-31 |
| Terminated | 2023-09-12 |
| Distributed | AL, CA, IL, KY, MN, MO, NC, NJ, NY, OH, OR, PA, TX |
| Quantity | 50 units |
| UPC / GTIN / UDI-DI | 00850014110147 |
| Serial numbers | 16145, 16151, 16154, 16171, 16177, 16179, 16196, 16201, 16204, 16211, 16212, 16219, 16220, 16235, 16244, 16247, 16260, 16270, 16273, 16298, 16304, 16309, 16313, 16319, 16338 and 25 more |
| Model numbers | AP03000H |
Product
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Reason for recall
Higher than expected flow rate.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1522-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.