OriGen Reinforced Dual L: Separation Risk Causes Blood Loss
OriGen recalls Reinforced Dual Lumen catheters with lot numbers N18487 and N18487-1 due to risk of clear tube separation causing blood loss. Affected patients should contact for remedy.
Stop using this now
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).
Contact the company
What happened, in plain English
OriGen is recalling specific catheters that can separate, leading to blood loss. This is serious and requires immediate action to prevent injury. Read more at govinfonow.com/recall/73264-origen-reinforced-dual-l-separation-risk-causes-blood-loss.
Source Summary by GovInfoNow · govinfonow.com/recall/73264-origen-reinforced-dual-l-separation-risk-causes-blood-loss · Updated September 19, 2026 · FDA enforcement record: FDA #Z-0021-2018
Cite this page
“OriGen Reinforced Dual L: Separation Risk Causes Blood Loss.” GovInfoNow, updated September 19, 2026. https://govinfonow.com/recall/73264-origen-reinforced-dual-l-separation-risk-causes-blood-loss. Based on FDA recall #Z-0021-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0021-2018%22&limit=1).
Why it’s dangerous
The catheter's clear extension tube can separate from the hub connection, causing blood loss. This has happened to two patients, resulting in injury.
Who’s affected
Patients using the recalled catheters are at risk of blood loss if the tube separates. Healthcare providers who have these catheters in use should act quickly.
How to tell if you have this one
Check for lot numbers N18487 or N18487-1 on the catheter packaging. The catheter has a wire reinforcement layer on the tip and a thin sheath covering it.
- Brand
OriGen- Category
Medical device
What to do — step by step
Stop Using Now
Immediately stop using the catheter if it has lot numbers N18487 or N18487-1.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 6.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0021-2018 (August 2, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0021-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.