Recall Z-3327-2026 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
SPECTRUM MEDICAL SRL
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 flo
| Date | Sep 29, 2026 (initiated Jul 17, 2026) |
| Status | Open, Classified |
| Reason | Due to blood-to-glycol leak in the heat exchanger. |
| Root cause | Process design |
| Action | 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 th |
| Quantity | 9448 |
| 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. |
| FDA record | Open on fda.gov |