Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies Recalled by Maquet Cardiovascular Us Sales, Llc Due to There is the potential for contaminated water to...
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 Maquet Cardiovascular Us Sales, Llc directly.
Affected Products
Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
Quantity: 305 units
Why Was This Recalled?
There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Maquet Cardiovascular Us Sales, Llc
Maquet Cardiovascular Us Sales, Llc has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report