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News & Insights

OriGen Biomedical Issues Nationwide Recall of RDLC ECMO Catheter

News & Insights

On August 17, 2018, OriGen Biomedical has initiated a voluntary nationwide recall of OriGen RDLC ECMO catheters. The product has been found to have certain deficiencies listed on the full notice, which could potentially increase recirculation. There is no related recall.

Customers who have products listed below should return these products to OriGen.
Recalled Product was manufactured from March 2015 through Sept 2017 and distributed
from March 2015 through March 2018.

The following products have been recalled:

Product Name: OriGen Biomedical RDLC ECMO Catheters

Lot Number Model Number
N18431-1 23F
N18446 16F
N18447 19F
N18447-1 19F
N18447-1A 19F
N18640 16F
N18640-1 16F
N18687-1 13F
P18806 32F
P18909 19F
P18971 19F
R19169 28F
R19208 16F
R19506 13F
S19746 13F
S19760 13F
S19761 13F
S19772 13F
S19781 13F
S19880 13F

 

Please note that no injury or adverse events have been reported in any of the devices
included in this recall.

OriGen Biomedical is notifying its distributors and customers by email and is arranging for return
of all recalled products. OriGen Biomedical distributed products to physicians and distributors in
the United States and Internationally.

Consumers with questions may contact the company via telephone at 1-800 233 9014 between the
hours of 08:00 and 16:30 (CDT). Customers outside the USA may contact OriGen at
+1.512.474.7278. Customers may also contact the company via e-mail at ecmo@origen.com. We
appreciate your immediate attention to this and value your continued understanding.

Adverse reactions or quality problems experienced with the use of this product may be reported to
the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-
332-1088 to request a reporting form, then complete and return to the address on the preaddressed
form, or submit by fax to 1-800-FDA-0178