Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange Recalled by Terumo Cardiovascular Systems Corporation Due to During an in-process inspection, Terumo Cardiovascular Systems (Terumo...
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
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Quantity: 30 units
Why Was This Recalled?
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow¿ Aortic Cannulae and Sarns" Venous Return Cannulae.
Where Was This Sold?
This product was distributed to 9 states: CA, LA, MA, MI, MO, OK, TX, 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