FDA-Device2026-10-07Class IIPROCESSING DEFECT
Spectrum Medical Quantum PureFlow heat exchanger recalled for blood-to-glycol leak risk
What this means
Spectrum Medical's Quantum PureFlow Standard Heat Exchanger (model HX55W-S0) may develop leaks that allow glycol coolant to mix with blood during cardiopulmonary bypass surgery. This device is used in operating rooms to regulate blood temperature during heart procedures. The affected lot (18051160301178) was distributed nationwide.
- If you operate or manage a cardiac surgical facility, identify any units from lot 18051160301178 in your inventory.
- Do not use affected units for new procedures.
- Contact Spectrum Medical or the FDA for guidance on device replacement or corrective actions.
- Report any adverse events to Spectrum Medical or the FDA MedWatch program.
The agency's original wording
Hazard
Due to blood-to-glycol leak in the heat exchanger.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of AL, CA, FL, KS MA, MD, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WI.
Affected count
3232
Manufactured in
Via Di Mezzo 23, Mirandola, Italy
Products
Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 Model/Catalog Number: HX55W-S0 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3328-2026More Spectrum Medical recalls
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