CLASS I Device recall · Reported 1 Nov 2017 · FDA Enforcement Report
The OriGen Reinforced Dual Lumen catheter recalled by OriGen Biomedical
OriGen Biomedical is recalling The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire, distributed nationwide in the US. The recall was initiated on 2 Aug 2017 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0021-2018
- FDA event ID
- 78033
- Recalling firm
- OriGen Biomedical, Austin, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 2 Aug 2017
- FDA classified
- 20 Oct 2017
- Reported
- 1 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 2 Aug 2017 | Recall initiated by company | |
| 20 Oct 2017 | Classified by FDA | +79 days |
| 1 Nov 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire recalled?
Yes. OriGen Biomedical recalled The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire on 2 Aug 2017. The recall is Class I and its status is Terminated. Recall number Z-0021-2018.
Why was it recalled?
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).
Which lots are affected?
Lot Numbers: N18487, N18487-1
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from OriGen Biomedical
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Accessory Sets Syringes: syringe with a female luer recalled | OriGen Biomedical | Sterility | 11 states |
| Device | CLASS III | Evolve Cell Culture, part numbers: EV1000N recalled by OriGen Biomedical | OriGen Biomedical | Labeling Errors | 19 states |
| Device | CLASS II | 3/8" FloPump, (Sterile) recalled by OriGen Biomedical | OriGen Biomedical | Sterility | TX |
| Device | CLASS I | ECMO Reinforced Dual Lumen Cannula, Sterile EO recalled | OriGen Biomedical | Lead & Heavy Metals | 33 states |
| Device | CLASS I | ECMO Reinforced Dual Lumen Cannula, Sterile EO recalled | OriGen Biomedical | Lead & Heavy Metals | 33 states |
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