OriGen VV28F Reinforced Dual Lumen ECMO Catheters: Recall - Potential for Separation of Extension Tube From Hub

From FDA - September 13, 2017

[Posted 09/13/2017]

AUDIENCE: Risk Manager, Emergency Medicine, Surgery

ISSUE: OriGen Biomedical initiated a nationwide recall for two (2) lots of VV28F Reinforced Dual Lumen ECMO Catheters. These VV28F Reinforced Dual Lumen ECMO Catheters have been found to have the potential for a separation of the clear extension tube from the hub that it is inserted in, which potentially could result in required intervention to prevent permanent impairment/damage.

OriGen Biomedical is aware of two (2) product failures and has received two (2) complaints associated with the problem. A recurrence of this event could result in serious patient injury.

OriGen VV28F Reinforced Dual Lumen ECMO Catheters described below have been recalled:

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