Z-0021-2018Class I

The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on...

Name: Z-0021-2018 The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on...
Creator: OriGen Biomedical, Inc.
Published: 2017-08-02
License: https://open.fda.gov/license/

OriGen Biomedical, Inc. / initiated 2017-08-02 / Terminated

FDA source

OriGen Biomedical, Inc. began a recall of 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... on 2017-08-02. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0021-2018
Classification: Class I
Status: Terminated
Initiated: 2017-08-02
Posted: 2017-10-20
Terminated: 2024-02-29
Recalling firm: OriGen Biomedical, Inc.
Product: 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 code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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).
FDA root cause: Under Investigation by firm
Action: The firm initiated their recall by letter on 08/02/2017, following with a press release on 08/28/2017. The firm sent a revised letter to include instructions for the distributors on 09/22/2017 and an updated press release was sent on 09/26/2017. The firm requested that the consignee discontinue use of all OriGen VV28F Reinforced Dual Lumen ECMO Catheters from lots N18487 and N18487-1 and return any of those lots to OriGen Biomedical immediately for replacement or product credit.
Quantity in commerce: 180 units
Distribution: 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.
Product codes and lots: Lot Numbers: N18487, N18487-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0021-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0021-2018	Class I	Terminated	Voluntary: Firm initiated	2017-11-01	2017-10-20

Product code DWF

K113869Class IIOrigen Reinforced Dual Lumen CatheterOrigen Biomedical, Inc. / cleared 2012-07-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)