Lower riskMedical device recall · FDA · Published August 21, 2018
OriGen Reinforced Dual Lumen Cannula Recall: Barium Sulfate Omission Risk
OriGen recalls 32Fr Reinforced Dual Lumen Cannulas (REF: VV3: VV32F) due to potential barium sulfate omission and incorrect tip length. This affects medical use in extracorporeal life support.
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
“OriGen Reinforced Dual Lumen Cannula Recall: Barium Sulfate Omission Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69989-origen-reinforced-dual-lumen-cannula-recall-barium-sulfate-omission-risk. Based on FDA recall #Z-0184-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0184-2019%22&limit=1).
The FDA announced on Aug. 21, 2018, that OriGen Biomedical Inc. recalled its Reinforced Dual Lumen Cannula due to potential barium sulfate omission and a tip length shorter than printed. The agency classified the recall as Class II.
How to tell if you have it
Brand: OriGen
Product: Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO
Lot: P18806
UDI: 00816203022148
The hazard
According to the FDA, these catheters may have barium sulfate omitted from their construction. Additionally, the actual catheter tip length is one centimeter shorter than what is printed on the tip.
Context
GovInfoNow's records show OriGen Biomedical Inc. has five other recalls on record since Aug. 2, 2017. Other recent recalls of similar products include Medtronic Pediatric Cannula Recall (May 25, 2026), Medtronic DLP Cannula Recall (April 21, 2026), and Medtronic DLP Retrograde Cannula Recall (April 21, 2026).
How to tell if you have this one
Check for the model number REF: VV32F on the packaging or label. The cannulas are sterile and intended for extracorporeal life support procedures.
Brand
OriGen
Category
Medical device
FDA recall event · 6 products
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
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.
Recall number
Product, codes & lots
Quantity
Z-0179-2019
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, 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.; UDI: 00816203022059, Lot: N18687, N18687-1, R19506, S19746, S19760, S19761, S19772, S19781, S19880, N18549, N18573
1517
Z-0180-2019
Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, 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.; UDI 00816203022073, Lot: N18404, N18446, N18640, N18640-1, R19208
452
Z-0181-2019
Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, 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.; UDI: 00816203022097, Lot: N18394, N18447, N18447-1, N18447-1A, P18909, P18971
435
Z-0182-2019
Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, 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.; UDI: 00816203022103, Lot: N18431, N18431-1
169
Z-0183-2019
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.; UDI: 00816203022124, Lot: N18487, N18487-1, N18561-1, R19169
241
Z-0184-2019
Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, 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.; UDI: 00816203022148, Lot: P18806
73
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the model number REF: VV32F on the packaging or label to confirm if it is recalled.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 34 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0184-2019 (August 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0184-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.