# FDA recall Z-0021-2018

> **OriGen Biomedical, Inc.** · Class I · device recall initiated 2017-08-02.

## 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).

## Distribution

US Nationwide and the countries of Austria, Belgium, Chile, Czech Republic, Italy, Kingdom of Saudi Arabia, Netherlands, Poland, Sweden, Thailand, Colombia, India, South Africa, United Arab Emirates.

## Key facts

- **Recall number:** Z-0021-2018
- **Recalling firm:** OriGen Biomedical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-02
- **Report date:** 2017-11-01
- **Termination date:** 2024-02-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0021-2018

## Citation

> AI Analytics. FDA recall Z-0021-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0021-2018. Source: US FDA. Licensed CC0.

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