Quantum Perfusion Blood Oxygenator VT200-E1Recalls & reported problems
Spectrum Medical Srl · Class 2
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 08051160300679), received between May 26, 2026 and May 26, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Insufficient Device Problem Information1
- Leak/Splash1
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.
MalfunctionMay 26, 2026Fluid/Blood Leak; Leak/Splash; Insufficient Device Problem Information
(B)(6) RECEIVED 3 VT200'S WITH LOT NUMBER J000078. UNFORTUNATELY, THEY USED ALL 3 PRIOR TO US LETTING THEM KNOW OF THE LEAKING POSSIBILITY, AND ALL THREE WERE LEAKING, ONE BEING ON A PATIENT. 2 WERE THROWN AWAY, BUT THEY DO STILL HAVE ONE THAT WAS REMOVED FROM A PRIMED CIRCUIT DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25276083 ↗
Other Oxygenator, Cardiopulmonary Bypass devices
- HLS Set BEQ-HLS 7050 USAMaquet Cardiopulmonary AG · Oxygenator, Cardiopulmonary Bypass3 recalls13 deaths90 reports
- Affinity Fusion® BB811Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls90 reports
- HLS Set BEQ-HLS 5050 USAMaquet Cardiopulmonary AG · Oxygenator, Cardiopulmonary Bypass3 recalls4 reports
- NA HLS Set Advanced 5.0, Small Adult, BIOLINE CoatingMaquet Cardiopulmonary AG · OXYGENATOR, CARDIOPULMONARY BYPASS3 recalls0 reports
- A.M.G. PMP Sterile A.M.G. Module PMP NO T.P. SterileEurosets Srl · Oxygenator, Cardiopulmonary Bypass2 deaths106 reports
- CAPIOX®FX CX*FX25RWTerumo Corporation · Oxygenator, Cardiopulmonary Bypass2 deaths102 reports
- CAPIOX®RX CX*RX25RWTerumo Corporation · Oxygenator, Cardiopulmonary Bypass1 death102 reports
- QUADROX-i HMO 50000-USA #SQUADROX-i Small Adult, no FilterMaquet Cardiopulmonary AG · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 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