Data Foundry

Medical device recalls 2026

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump — Class II medical device recall Z-2580-2026

Completed recall by Boston Scientific Corporation, reported 2026-07-01, distributed nationwide. There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

Recall numberZ-2580-2026
Product typeMedical device
ClassificationClass II
StatusCompleted
Voluntary or mandatedVoluntary
Recalling firmBoston Scientific Corporation, Maple Grove, MN, United States
Recall initiated2026-05-11
Classified2026-06-25
Reported by FDA2026-07-01
DistributedNationwide (US)
Quantity1 devices
Reason classespackaging
UPC / GTIN / UDI-DI00850014110147
Serial numbers20175

Product

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device

Reason for recall

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

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-2580-2026. 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.