OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Adhesive Failure Risk
OriGen Biomedical is recalling 260 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of tube disconnection caused by adhesive failure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (ECMO cannula) where a mechanical failure (tube disconnection) poses a significant risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
OriGen Biomedical, Inc. is recalling 260 units of the ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F. The recall involves specific lots: N18446, N18640-1, R19208, and R19406. The product was distributed across 35 U.S. states and the District of Columbia, as well as 20 foreign countries.
The recall is due to a potential defect where clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, resulting in the clear tube disconnecting from the hub.
Healthcare providers and facilities that have received these specific lots should stop using the affected cannulas and contact OriGen Biomedical for instructions on return or replacement. Patients who have received these devices should consult their healthcare provider regarding the recall.
The recalled product
- Product
- ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
- Manufacturer
- OriGen Biomedical, Inc.
- Category
- Medical Device — ECMO Cannula
- Affected units
- 260
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lots: N18446
- N18640-1
- R19208
- R19406
Distribution
Part of a larger recall action
This product is one of 6 recalled by OriGen Biomedical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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- Severe