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

[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:

• Catalog number VV28F, Lots N18487 & N18487-1

BACKGROUND: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.

RECOMMENDATION: OriGen Biomedical is notifying distributors and user facilities by e-mail and is arranging for return of all recalled product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/22/2017 - Press Release - OriGen Biomedical]