Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W HX55V-S0WRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18051160302205), received between Nov 21, 2025 and May 19, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K223879); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 17, 2026Class IIOpen, Classified

   Due to blood-to-glycol leak in the heat exchanger.

   Z-3327-2026 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Fluid/Blood Leak

  BLOOD NOTED IN GLYCOL COMPARTMENT OF HEX - APPEARED TO BE A FAULT IN THE SEAM LINE BETWEEN THE GLYCOL COMPARTMENT AND THE BLOOD CHANNEL. DID NOT APPEAR TO RUPTURE, BLOOD APPEARED TO BE CONTAINED. CLINICIAN DISCARDED THE HEX FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25213370 ↗
• InjuryDec 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  USER REPORTED A BLOOD TO GLYCOL LEAK DURING THE CASE. NO ADVERSE CONSEQUENCES OCCURRED FOR THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23772177 ↗
• MalfunctionNov 21, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  USER REPORTED SIGNS OF DAMAGE TO THE STERILE PRIMARY PACKAGING (BLISTER) BEFORE USE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23616348 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K223879. One submission often covers many models, so check the product and lot details in each record.

• Z-3328-2026 · Jul 17, 2026 · Open, Classified
  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 Quan