Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 Model/Catalog Number
Summary
The FDA issued a Class II for Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Excha by SPECTRUM MEDICAL SRL. Reason: Due to blood-to-glycol leak in the heat exchanger..
Details
Source
Device Recall
External ID
Z-3328-2026
Action Date
2026-10-07
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Lot Code: 18051160301178 (HX55W-S0)
Quantity Affected: 3232
Reason for Recall
Due to blood-to-glycol leak in the heat exchanger.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-17
Company
Mirandola
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 238 device recalls issued in the same week, part of 518 device-related FDA actions this month.
SPECTRUM MEDICAL SRL has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SPECTRUM MEDICAL SRL) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SPECTRUM MEDICAL SRL have FDA actions?
SPECTRUM MEDICAL SRL has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3328-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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