Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Custom Cardiovascular Procedure Kits Recalled by Terumo Cardiovascular Systems Corp Due to The Overpressure Safety Valve is not cleared with...
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 Corp directly.
Affected Products
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
Quantity: 163 devices
Why Was This Recalled?
The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.
Where Was This Sold?
This product was distributed to 2 states: FL, MO
About Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Systems Corp has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report