Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel Recalled by OriGen Biomedical, Inc. Due to Two users have reported to OriGen that a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact OriGen Biomedical, Inc. directly.
Affected Products
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.
Quantity: 180 units
Why Was This 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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About OriGen Biomedical, Inc.
OriGen Biomedical, Inc. has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report