Critical RiskFDA Device

OriGen Biomedical, Inc.: 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, with subsequent clear tube disconnect from the hub.

Agency Publication Date: June 4, 2019

Affected Products

Product: ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F

Lots: N18446, N18640-1, R19208, R19406

Product: ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F

Lots: N18431, N18431-1, R19280, R19281

Product: ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F

Lots: P18806, R19368

Product: ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F

Lots: N18573, N18687-1

Product: ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F

Lots: N18447-1A, P18909, P18971

Product: ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F

Lots: N18487, N18487-1, N18561-1, R19169

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82512

Status: Resolved

Manufacturer: OriGen Biomedical, Inc.

Manufactured In: United States

Units Affected: 6 products (260; 72; 66; 145; 61; 66)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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