Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Recalled by Terumo Cardiovascular Systems Corp Due to Defect in the luer connector can compromise the...
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
Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4:1 ratio. In includes a Conducer Heat Exchanger and a Bubble Trap module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity
Quantity: 596 units; 876 units
Why Was This Recalled?
Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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