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, used during heart-lung bypass surgery, can develop leaks that allow glycol coolant to mix with blood. The affected devices are model HX55V-S0W from lot code 18051160302205. No injuries have been reported.
- If your facility received lot 18051160302205, stop using affected units immediately.
- Contact Spectrum Medical or your distributor for replacement devices or instructions.
- Review your inventory to identify affected serial lots before your next scheduled bypass procedure.
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
9448
Manufactured in
Via Di Mezzo 23, Mirandola, Italy
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3327-2026More Spectrum Medical recalls
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