The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Recalled Product: OriGen VV28F Reinforced Dual Lumen ECMO Catheter
- Product Code: DWF
- Product Lot Numbers: N18487, N18487-1
- Distribution Dates: August 14, 2014 to November 29, 2016
- Manufacturing Dates: August 14, 2014 to April 15, 2015
- Devices Recalled in the U.S.: 104 nationwide
The OriGen Reinforced Dual Lumen catheter is intended to be used for venous drainage and arterial reinfusion of blood through the internal jugular vein, a major blood vessel in the neck, during life support procedures of six hours or less.
Reason for Recall
OriGen Biomedical is recalling the Reinforced Dual Lumen catheter due to a risk of a separation of the clear extension tube from the hub connection. If separation occurs, it can result in serious adverse health consequences such as blood loss, prolonged hypotension, low cardiac output, and/or cardiopulmonary arrest.
Who May be Affected
- Health care providers using the OriGen Reinforced Dual Lumen catheter.
- Patients undergoing life support treatments such as cardiopulmary bypass procedures with the use of these catheters.
What to Do
On August 2, 2017, OriGen Biomedical sent an Urgent Medical Device Recall Notice to all affected customers and distributors. The notice asked them to:
- Discontinue use of Reinforced Dual Lumen catheter from lots N18487 and N18487-1.
- Return affected catheters to OriGen Biomedical immediately for replacement or product credit.
- Complete and return the acknowledgement and receipt form even if there are no affected products in the inventory.
Customers or distributors with questions may contact OriGen Biomedical at:
Phone: +1 512 474 7278 CST Monday – Friday 8:00-5:00
Fax: +1 512 617 1503
Date Recall Initiated
August 2, 2017
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.