The OriGen Reinforced Dual Lumen catheter — Class I medical device recall Z-0021-2018
Terminated recall by OriGen Biomedical, Inc., reported 2017-11-01, distributed nationwide. Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a separation
| Recall number | Z-0021-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OriGen Biomedical, Inc., Austin, TX, United States |
| Recall initiated | 2017-08-02 |
| Classified | 2017-10-20 |
| Reported by FDA | 2017-11-01 |
| Terminated | 2024-02-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, CL, CO, CZ, IN, IT, NL, PL, SA, SE, TH, ZA |
| Quantity | 180 units |
| Lot numbers | N18487, N18487-1 |
Product
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
Reason for recall
Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a separation of the clear extension tube from the hub connection. These adverse events resulted in patient injury (blood loss).
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-0021-2018. 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.