ClariVein IC infusion catheter — Class II medical device recall Z-1146-2018
Terminated recall by Vascular Insights, LLC, reported 2018-03-28, distributed nationwide. Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in
| Recall number | Z-1146-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vascular Insights, LLC, Quincy, MA, United States |
| Recall initiated | 2017-11-09 |
| Classified | 2018-03-20 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2018-12-18 |
| Distributed | Nationwide (US) |
| Quantity | 928 |
| Lot numbers | BM651403017I |
| Model numbers | 65-018-E4S |
Product
ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.
Reason for recall
Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction of the catheter into a vascular access introducer.
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-1146-2018. 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.