Quantum PureFlow Standard Heat Exchanger High Flow 3/8 HX55W-S0Recalls & reported problems
Spectrum Medical Srl · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08051160301171), received between Nov 7, 2025 and Nov 25, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (4 reports).
2 other recalls cover devices cleared under the same FDA submission (K212688, K220110, 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.
Reports received per month
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 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 23643758 ↗MalfunctionNov 25, 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 23642763 ↗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 23614817 ↗MalfunctionNov 7, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
USER REPORTED MULTIPLE HX WITH 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 23495994 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K212688, K220110, K223879. One submission often covers many models, so check the product and lot details in each record.
- Z-3327-2026 · Jul 17, 2026 · Open, ClassifiedBrand 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 Q
- Z-3328-2026 · Jul 17, 2026 · Open, ClassifiedBrand 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
Other Heat-Exchanger, Cardiopulmonary Bypass devices
- Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. 3CX*FX25RECTerumo Cardiovascular Systems Corporation · Heat-Exchanger, Cardiopulmonary Bypass3 deaths267 reports
- QUADROX-i HMO 51000-USA #SQUADROX-i Small Ad.+Filter /Small Adult. FilterMaquet Cardiopulmonary AG · HEAT-EXCHANGER, CARDIOPULMONARY BYPASS2 recalls0 reports
- QUADROX-i BEQ-HMO 71000-USA #SQUADROX-i Adult+BIOLINE +FilterMaquet Cardiopulmonary AG · HEAT-EXCHANGER, CARDIOPULMONARY BYPASS2 recalls0 reports
- QUADROX-iD BEQ-HMOD70000-USA #SQUADROX-iD Ad./coated/ no.Fil.Maquet Cardiopulmonary AG · HEAT-EXCHANGER, CARDIOPULMONARY BYPASS2 recalls0 reports
- QUADROX-i Pediatric, diffusion, BIOLINEMaquet Cardiopulmonary AG · HEAT-EXCHANGER, CARDIOPULMONARY BYPASS2 recalls0 reports
- MPS2 Console 5201260Quest Medical Inc · Heat-Exchanger, Cardiopulmonary Bypass1 death67 reports
- Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W HX55V-S0WSpectrum Medical Srl · Heat-Exchanger, Cardiopulmonary Bypass1 recall3 reports
- Quadrox-iD BEQ-HMOD30000-USAMaquet Cardiopulmonary AG · Heat-Exchanger, Cardiopulmonary Bypass1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page