Quadrox-i SQUADROX-i HMO 70000+ VHK7000Recalls & reported problems
Maquet Cardiopulmonary AG · Quadrox-i Hollow Membrane Oxygenator, Adult, with VHK Reservior, unsealed, with Universal Adaptor, without Filter; vacuum-tight, non-Coated, Sterile. The QUADROX-i Adult oxygenators are blood-gas exchangers with integrated heat exchanger and optionally integrated arterial blood filter. They are used in cardiac surgery, in combination with a heart-lung machine, to oxygenate blood, remove carbon dioxide and adjust blood temperature. · Class 1
All models of QUADROX-i (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04058863017792), received between Feb 27, 2025 and Feb 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).
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
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT AT THE END OF THE TREATMENT THERE WAS A CLOT IN THE OXYGENATOR. THE PRODUCT WAS USED FOR ONE AND HALF HOURS. CUSTOMER STATES THAT THERE WAS NOT A SIGN OF POOR FUNCTION OF OXYGENATOR WAS DETECTED, FLOWS AND OXYGENATION WERE NOT AFFECTED. SINCE THE DEVICE HAD A CLOTTING DURING PATIENT TREATMENT AND THEREFORE THE DEVICE DID NOT FUNCTION AS EXPECTED, AS THIS COULD LEAD TO LACK OF FLOW/OXYGENATION THE COMPLAINT IS REPORTABLE. COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21478899 ↗
Other Antigens, Cf (Including Cf Control), Adenovirus 1-33 devices
- InflammaDry RPS-ID-20-UQuidel Corporation · ANTIGENS, CF (INCLUDING CF CONTROL), ADENOVIRUS 1-331 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.
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