Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or 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 Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The 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: 135,340 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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