OriGen Biomedical, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0021-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.

Product Classification:

Class I

Date Initiated: August 2, 2017

Date Posted: November 1, 2017

Recall Number: Z-0021-2018

Event ID: 78033

Reason for Recall:

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 patient injury (blood loss).

Status: Terminated

Product Quantity: 180 units

Code Information:

Lot Numbers: N18487, N18487-1

Distribution Pattern:

US Nationwide and the countries of Austria, Belgium, Chile, Czech Republic, Italy, Kingdom of Saudi Arabia, Netherlands, Poland, Sweden, Thailand, Colombia, India, South Africa, United Arab Emirates.

Voluntary or Mandated:

Voluntary: Firm initiated