Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula Recalled by Terumo Cardiovascular Systems Corporation Due to The presence of plastic flash was identified at...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Terumo Cardiovascular Systems Corporation directly.
Affected Products
24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Quantity: 5760 total
Why Was This Recalled?
The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl
Where Was This Sold?
This product was distributed to 28 states: AL, CA, CO, DE, FL, GA, IL, IN, KS, KY, LA, MA, MI, MS, MO, MT, NE, NH, NY, NC, ND, OH, PA, TN, TX, VA, WI, DC
About Terumo Cardiovascular Systems Corporation
Terumo Cardiovascular Systems Corporation has 204 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report