FDA Medical Device Recalls (openFDA)
OriGen Biomedical, Inc.: ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula 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.
- Recall number
- Z-0183-2019
- Recalling firm
- OriGen Biomedical, Inc.
- Product
- ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula 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.
- Status
- Terminated
- Initiated
- 2018-08-21
- Posted
- not on file
- Terminated
- 2021-07-15
- Reason
- 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
- Root cause
- Component design/selection
- Action
- On 08/21/18, the firm, OriGen, emailed a recall notice dated 8/17/2018 to customers informing them of a nationwide recall of RDLC ECMO catheters. Customers were advised to return affected product to the firm. Customers with additional questions were advised to call 1-800-233-9014 or 1-512-474-7278. The firm also sent customers Technical Bulletin (TB) 1411 - Revision Feb 2018, Subject: Radiopacity of the Reinforced Dual Lumen Catheter (RDLC), Date: July 2015, and an Acknowledgment Receipt form to complete and return. On 09/12/18, the firm, Origen, sent another recall notice, dated 9/12/2018 which included additional affected lot numbers. TB1411 was sent to customers three additional times (Version/Customer Notification Date): R00/11/10/14, R01/07/22/15, and Revision Feb 2018/02/12/18. 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.
- Quantity
- 241
- Distribution
- Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL, AR, MO, GA, LA, DC, OR, MN, SC, OK, AZ, UT, RI, SD, WA, PA, AL, MD, IL, HI; and countries (OUS) of: Argentina, Austria, Belgium, CANADA, Colombia, EU, Germany, India, Italy, Japan, Kingdom of Saudi Arabia, Netherlands, New Zealand, Poland, Qatar, Romania, South Africa, SWEDEN, Thailand, UK, United Arab Emirates, and VIETNAM.
- Lot, serial or model codes
- UDI: 00816203022124, Lot: N18487, N18487-1, N18561-1, R19169
- 510(k) numbers
- ["K113869"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 1000160256
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28