Nationwide Catheter Recall by OriGen Biomedical: VV13F Reinforced Dual Lumen Extra-Corporeal Membrane Oxygenation (ECMO) Catheters

Nationwide Catheter Recall by OriGen Biomedical: VV13F Reinforced Dual Lumen Extra-Corporeal Membrane Oxygenation (ECMO) Catheters

Article
Vein & Vascular Health
Kids' Zone
+2
Contributed byKrish Tangella MD, MBAApr 21, 2015

The Food and Drug Administration (FDA) has announced that OriGen Biomedical has initiated a nationwide recall of one lot of its VV13F Reinforced Dual Lumen ECMO Catheters. The catheters’ clear extension tube could possibly separate from where it is inserted in the hub. This could lead to the treatment/intervention being rendered ineffective.

The term Extra-Corporeal Membrane Oxygenation means “heart-lung bypass,” in which a machine outside the body will take over the heart’s function in order to provide enough oxygen through blood circulation, so that the lungs and heart could rest and heal.

ECMO treatment is used in very young infants with a heart or breathing problem, in cases where the condition is considered reversible. It may also be used in infants who are very ill and are awaiting a heart or lung transplant.

The following are the details on lot number, date of manufacture, and expiration of the recalled ECMO product:

Lot N18549, 238 Units

Manufactured 09/2014, distributed Feb 16- March 26, 2015

Expiration 09/2018

 

Distributed to ECMO sites in California, Michigan, Ohio, Oregon, Texas, Indiana, New York, Florida, Pennsylvania, Hawaii, Kentucky

According to the FDA, “The OriGen VV13F Reinforced Dual Lumen ECMO Catheters is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less in Neonatal Intensive Care and Pediatric Intensive Care ECMO centers.”

Thus far, it has been reported that there was one serious adverse event, resulting in serious patient injury.

Customers are requested to return any product from OriGen of the above-mentioned lot to the company. The contact details are given below:

 

OriGen Biomedical

Attn: Bernie R Silvers

7000 Burleson Rd, Bldg. D

Austin, TX 78744

 Monday – Friday 8:00-5:00 (CST)

Telephone: 512 474 7278

 

Customers could also report adverse events to FDA by calling 1-800-332-1088, by fax at 1-800-FDA-0178 or online at www.fda.gov/medwatch/report.htm.

 


References:

(2015 Apr 15). OriGen Biomedical Issues Nationwide Recall of OriGen VV13F Reinforced Dual Lumen ECMO Catheters. Retrieved from http://www.fda.gov/Safety/Recalls/ucm443009.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Kaneshiro, N.K. (2014 Feb 26). Extracorporeal membrane oxygenation. Retrieved from http://www.nlm.nih.gov/medlineplus/ency/article/007234.htm

Introduction to ECMO for Parents. Retrieved from https://lane.stanford.edu/portals/cvicu/HCP_CV_Tab_1/ecmo_for_parents.pdf

(2013 Dec). What is Cardiopulmonary Bypass? Retrieved from http://www.cincinnatichildrens.org/health/c/bypass/

 

Was this article helpful

On the Article

Krish Tangella MD, MBA picture
Approved by

Krish Tangella MD, MBA

Pathology, Medical Editorial Board, DoveMed Team

0 Comments

Please log in to post a comment.

Related Articles

Test Your Knowledge

Asked by users

Related Centers

Loading

Related Specialties

Loading card

Related Physicians

Related Procedures

Related Resources

Join DoveHubs

and connect with fellow professionals

Related Directories

Who we are

At DoveMed, our utmost priority is your well-being. We are an online medical resource dedicated to providing you with accurate and up-to-date information on a wide range of medical topics. But we're more than just an information hub - we genuinely care about your health journey. That's why we offer a variety of products tailored for both healthcare consumers and professionals, because we believe in empowering everyone involved in the care process.
Our mission is to create a user-friendly healthcare technology portal that helps you make better decisions about your overall health and well-being. We understand that navigating the complexities of healthcare can be overwhelming, so we strive to be a reliable and compassionate companion on your path to wellness.
As an impartial and trusted online resource, we connect healthcare seekers, physicians, and hospitals in a marketplace that promotes a higher quality, easy-to-use healthcare experience. You can trust that our content is unbiased and impartial, as it is trusted by physicians, researchers, and university professors around the globe. Importantly, we are not influenced or owned by any pharmaceutical, medical, or media companies. At DoveMed, we are a group of passionate individuals who deeply care about improving health and wellness for people everywhere. Your well-being is at the heart of everything we do.

© 2023 DoveMed. All rights reserved. It is not the intention of DoveMed to provide specific medical advice. DoveMed urges its users to consult a qualified healthcare professional for diagnosis and answers to their personal medical questions. Always call 911 (or your local emergency number) if you have a medical emergency!