# K113869: Origen Reinforced Dual Lumen Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Origen Biomedical, Inc.
- Decided: Jul 26, 2012 after 209 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 16 (9 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) OriGen Dual Lumen cannula: named in the summary without a submission number

## Recalls of this device
- Aug 21, 2018 · Class II · Z-0102-2019: The catheter failed the endotoxin testing.
- Aug 21, 2018 · Class II · Z-0179-2019: These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
- Aug 21, 2018 · Class II · Z-0183-2019: These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
- Aug 21, 2018 · Class II · Z-0180-2019: These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
- Aug 21, 2018 · Class II · Z-0181-2019: These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
- Aug 21, 2018 · Class II · Z-0182-2019: These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
- Aug 21, 2018 · Class II · Z-0184-2019: These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
- Aug 2, 2017 · Class I · Z-0021-2018: Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a separation of the clear extension tube from the hub connection. These adverse events resulted in pat
- Jan 17, 2017 · Class I · Z-1227-2019: 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 
- Jan 17, 2017 · Class I · Z-1231-2019: 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 
- Jan 17, 2017 · Class I · Z-1230-2019: 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 
- Jan 17, 2017 · Class I · Z-1232-2019: 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 
- Jan 17, 2017 · Class I · Z-1228-2019: 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 
- Jan 17, 2017 · Class I · Z-1229-2019: 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 
- Mar 30, 2015 · Class I · Z-0269-2019: Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage
- Mar 30, 2015 · Class I · Z-1456-2015: Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage.

## Indications for use
The OriGen Reinforced Dual Lumen Cannula 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.

Source page: https://510kreport.com/device/K113869
Methodology: https://510kreport.com/methodology