Device recall
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 number
- Z-3327-2026
- Event id
- 99462
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- SPECTRUM MEDICAL SRL
- Report date
- Oct 7, 2026
- Posted
- Sep 29, 2026
- Initiated
- Jul 17, 2026
- Center classification date
- Sep 29, 2026
- Product code
- DTR
- Device type
- Heat-Exchanger, Cardiopulmonary Bypass
- Reason
- Due to blood-to-glycol leak in the heat exchanger.
- Root cause
- Process design
- Quantity
- 9448
- Code info
- Lot Code: 18051160302205 (HX55V-S0W)
- Distribution
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Mirandola, Italy