SPECTRUM MEDICAL SRL recalls Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger Hi…

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

On 07/17/2026, an "URGENT MEDICAL DEVICE RECALL" letter was sent via email to customers informing them that, Spectrum Medical S.r.l. has received customer complaints reporting a leak between the blood and glycol compartments of certain adult heat exchangers. Actions to be taken by customers: During the procedure, the user should monitor the heat exchanger for leakage, which would be evident by a change in colour in the glycol compartment. Below are images of the heat exchanger if a blood-to-glycol leak was to occur. When operating as intended, the glycol compartment should remain clear. If the colour of the glycol compartment changes, then a leak is present between the blood and glycol compartments. If leakage is noted between the blood and glycol compartments of the heat exchanger, the heat exchanger should be immediately replaced in the circuit with a new device. Please return the defective heat exchanger to Spectrum Medical. The contaminated heater-cooler device should also be immediately removed from clinical use and returned to Spectrum Medical for decontamination and inspection. Do not use the heater-cooler with another patient. If leakage has occurred, please contact a Spectrum Medical representative to coordinate device return. If leakage into the water compartment occurs when using a third-party heater-cooler, the customer should immediately remove the heater-cooler from clinical use and contact the heater-cooler manufacturer. Spectrum Medical suggests that for customers that use the heat exchanger in combination with a third-party heater-cooler to contact the manufacturer of the heater-cooler to pre-emptively discuss the steps that should be taken if the device is exposed to blood contamination. For questions or further assistance - contact Regulatory Affairs Specialist at cameron.schmitt@spectrummedical.com

• FDA enforcement recordOfficial FDA database entry for Z-3328-2026
• FDA 510(k) clearance · K220110The device's official FDA premarket clearance record
• FDA 510(k) clearance · K223879The device's official FDA premarket clearance record
• FDA device classification · DTROfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.4240The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find SPECTRUM MEDICAL SRLSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.