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U.S. Department of Health and Human Services

Class 2 Device Recall Quantum PureFlow

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 Class 2 Device Recall Quantum PureFlowsee related information
Date Initiated by FirmJuly 17, 2026
Date PostedSeptember 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3328-2026
Recall Event ID 99462
510(K)NumberK220110 K223879 
Product Classification Heat-exchanger, cardiopulmonary bypass - Product Code DTR
ProductBrand 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
Code Information Lot Code: 18051160301178 (HX55W-S0)
FEI Number 3016746283
Recalling Firm/
Manufacturer		 SPECTRUM MEDICAL SRL
Via Di Mezzo 23
Mirandola Italy
For Additional Information ContactCameron Schmitt
1-803-8333964
Manufacturer Reason
for Recall		Due to blood-to-glycol leak in the heat exchanger.
FDA Determined
Cause 2		Process design
ActionOn 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
Quantity in Commerce3232
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DTR
510(K)s with Product Code = DTR
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