Official recall notice

FDA DeviceClass IINotable

Quantum PureFlow Standard Heat Exchanger High Recall (Oct 2026)

Product: Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W Software Version: N/A Product Description: The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration with a maximum flow rate of 8 l/min. Quantum PureFlow Standard Heat Exchanger is a single use device which allows heating/cooling the blood during extracorporeal circulation. The device is sold sterile in a blister pack in a multiple box of 4 units. Device surfaces in contact with blood are treated with a phosphorylcholine-based biocompatible coating. The device has been designed to be powered by heaters coolers that use water or a glycol-based heat transfer fluid (HTF). Component: N/A

Recall date
2026-10-07
FDA class
Class II

Why it was recalled

Hazard

Due to blood-to-glycol leak in the heat exchanger.

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Product description

Due to blood-to-glycol leak in the heat exchanger.

Affected products

Lot Code: 18051160302205 (HX55V-S0W)

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