Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors CP22V-VTRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08051160300624), received between Mar 10, 2023 and Feb 19, 2026 — classified as 1 death, 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 reports).

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

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. Jan 16, 2025Class IIOpen, Classified

   Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.

   Z-1327-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Insufficient Device Problem Information

  A SERIES OF CLOTS APPEARED IN THE CENTRIFUGAL HEADS. THE INCIDENT OCCURRED ON THE SAME PATIENT TWO DAYS APART. THE CIRCUIT WAS COMPLETELY CHANGED.

  Patient problems: Coagulation Disorder

  MAUDE report 24387184 ↗
• MalfunctionJan 8, 2026Detachment of Device or Device Component; Insufficient Device Problem Information

  USER REPORTED THAT PATIENT HAD BEEN ON SUPPORT FOR ABOUT 30 MINUTES, WHEN THE TIE-BANDED TUBING BECAME DISCONNECTED FROM THE OUTLET OF THE CP22V-VT. LINE PRESSURES ON THE P-OUT WERE READING <250MMHG AT THE TIME. BOTH THE PERFUSIONIST AND THE ECMO SPECIALIST CONFIRMED THE TUBING WAS ON PAST THE SECOND BARB AND THE TIE BAND WAS IN THE PROPER LOCATION AND SECURE. PATIENT WAS SUPPORTED MEDICALLY AND QUICKLY PUT ON ANOTHER SYSTEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24003631 ↗
• DeathDec 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  USER REPORTED THAT THREE CASES IN A ROW HAVE EXPERIENCED HIGH PFH (PLASMA FREE HEMOGLOBIN). IT WAS REPORTED THAT ALL THREE WERE DIFFERENT LOT NUMBERS. UNKNOWN THE PREVIOUS TWO LOT NUMBERS FOR THIS REPORT. THE HOSPITAL RECENTLY CHANGED LAB MACHINES FOR MEASURING PFH. NEW MACHINE REGISTERED MUCH HIGHER. THEY WERE NOT ABLE TO COMPARE ON PREVIOUS CASES, BUT THIS CASE THEY DID. PFH NEW MACHINE 200 AND 230 AND OLD METHOD WAS 50 AND 74 RESPECTIVELY. CASE BEFORE (TWO SAMPLES) WITH NEW MACHINE 350 AND 1040. CASE 3 BEFORE THAT TWO SAMPLE 220 AND 250. THEY USE MEDTRONIC TUBING AND EOS OXYGENATORS. RPM WAS REPORTED TO BE 3500-4000 TO MAINTAIN A FLOW OF 150 ML/KG (FLOW OF 0.55 LPM). SEEMS ELEVATED, BUT THE USER DID NOT IDENTIFY ANY REASON FOR IT. LINE PRESSURES 190-220 MMHG.

  Patient problems: Hemolysis

  MAUDE report 23887691 ↗
• InjuryOct 7, 2025Restricted Flow rate; Restricted Flow rate

  (B)(6), CCP CALLED REGARDING AN ISSUE THAT THEY HAD WITH A CP22-VT, NP1001865 CENTRIFUGAL DRIVE, PH6003247. THE GOAL FLOW FOR THE PATIENT WAS 0.5 LPM, HOWEVER, THE HIGHEST FLOW THEY WERE ABLE TO ACHIEVE WAS 15 LPM NO MATTER HOW HIGH THEY TURNED UP THE RPMS. THE HIGHEST OUTLET PRESSURE THEY ACHIEVED WAS 112 MMHG, AND THE INLET PRESSURE WAS AROUND -40 MMHG. THEY THOUGHT IT COULD HAVE BEEN THE CANNULATION, BUT WHEN THEY DID A CIRCUIT CHANGE TO A BIOMEDICUS PUMP, THEY WERE ABLE TO ACHIEVE THE GOAL FLOWS. THEY DID NOT REPORT ANY ALARM OR ALERTS AT THE TIME.

  Patient problems: Reduced Blood Flow

  MAUDE report 23231220 ↗
• MalfunctionSep 11, 2025Pumping Stopped; Pumping Stopped

  CP22 DISPOSABLE PORT ON THE INLET SIDE APPEARS TO HAVE CUT OUT DURING THE RUN. PERFUSIONIST STATES THAT THE INLET PRESSURE DECREASED TO -700, CAUSING THE PUMP TO STOP BEFORE THE INLET PRESSURE IN THE GUAGE BAR WENT COMPLETELY BLANK.

  Patient problems: Insufficient Information

  MAUDE report 23025462 ↗
• MalfunctionJul 2, 2025Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  AN ECPR SYSTEM WAS FOUND DEPRIMED OVERNIGHT BY AN ECMO TEAM MEMBER. AFTER CONFIRMING ALL CONNECTIONS TO BE IN GOOD STANDING- PUMP HEAD WAS ASSESSED AS LARGE FLUID COLLECTION FOUND IN DRIVE UNIT HOUSING. UPON INSPECTING PUMP HEAD- APPEARS TO HAVE HAIRLINE CRACK NEAR THE OUTLET CONNECTOR WHICH IS ASSUMED TO BE CAUSE. SYSTEM HAD PREVIOUSLY BEEN PRIMED TWO DAYS PRIOR AND STORED INSIDE OF LOCKED CLOSET.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22381183 ↗
• MalfunctionMay 15, 2025Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  PLASMA LEAKAGE FROM PUMP HEAD REQUIRING EMERGENT CHANGE OUT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22026252 ↗
• MalfunctionDec 19, 2024Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  BLOOD LEAKING FROM CENTRIFUGAL PUMP DURING CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20976119 ↗
• MalfunctionNov 20, 2024Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  HAS BEEN NOTED A PLASMA LEAKAGE. DURING CHANGE OUT AND PRIMING THE SECOND SYSTEM WERE FOUND PROBLEMS WITH THE PIN PRESSURE READING HIGH NEGATIVES EVEN THOUGH IT HAD BEEN ZEROED CORRECTLY. TRANSDUCERS WERE CONVERTED TO REGULAR WET TRANSDUCERS. THE CHANGE OUT PUMP HEAD IS THE SAME LOT NUMBER AS THE ONE LEAKING PLASMA. AFTER THEY CHANGED IT OUT THEY KEPT IT AND RINSED IT FOR RETURN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20731611 ↗
• MalfunctionJun 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  SUSPECTED DEVELOPMENT OF A CLOT AFTER 4 DAYS OF USING A CP22. THE DOCTOR SHARED THE PATIENMT'S ANTICOAGULATION HAD BEEN PAUSE FOR OVER 12 HOURS EHEN THE CLOT DEVELOPED. CLINICALLY NOTICED INCREASED DELTA P AND DECREASED FLOW. THE PATIENT'S CIRCUIT WAS ELECTIVELY CHANGED OUT, ANTICOAGULATION ADJUSTED, AND NO CLINICAL HARM TO PATIENT OCCURRED. PATIENT NEEDED 2 ADDITIONAL CIRCUIT CHANGES BEFORE WEANING OFF ECMO AT LATER DATE. NO PICTURES OR VIDEO AVAILABLE. AT PRESENT OF THIS FORM THE DEVICE IS STILL ON THE WAY BACK FOR INVESTIGATION. ONCE WE'LL RECEIVE THE DEVICE INVOLVED IN THIS EVENT WE'LL COLLECT FURTHER INFORMATION.

  Patient problems: Coagulation Disorder

  MAUDE report 19526714 ↗
• MalfunctionFeb 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS SHOWING SIGNS OF HEMOLYSIS, SO THE CIRCUIT WAS CHANGED OUT. THE SURGEON WOULD LIKE THIS DISPOSABLE SENT BACK TO ITALY FOR INVESTIGATION. NO SIGNS OF CLOT OF MANUFACTURER ERROR WERE OTHERWISE NOTICED. PATIENT WAS NOT HARMED DUE TO CHANGE OUT.

  Patient problems: Hemolysis

  MAUDE report 18765906 ↗
• MalfunctionJan 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PERFUSIONIST HAD CALLED WITH CONCERN THAT THE CENTRIFUGAL PUMP CP22V-VT WAS CAUSING HEMOLYSIS

  Patient problems: Hemolysis

  MAUDE report 18542459 ↗
• MalfunctionNov 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PROPELLER ON THE CP22 SEEMS TO BE OFF-CENTER. THIS WAS NOTICED AFTER THE CLINICIAN REPORTED INCREASED HEMOLYSIS IN THE PATIENT THAT HAD BEEN ON LESS THAN 24 HRS. CHANGE OUT THE CP22 AND THAT RESOLVED THE PATIENTS HEMOLYSIS ISSUES. AFTER THE PUMP CHANGE OUT, THE CLINICIAN SAW A THROMBUS ON THE BEARING OF THE PUMP THAT WAS JUST CHANGED OUT.

  Patient problems: Hemolysis

  MAUDE report 18235835 ↗
• MalfunctionMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICIAN CALLED TO REPORT THAT CP22 DISPOSABLE WAS CHANGED OUT DUE TO SIGNS OF HIGH HEMOLYSIS (HIGH PLASMA FREE HEMOGLOBIN AND RISING DELTA P) AFTER BEING ON ECMO FOR ~ 4 DAYS. AFTER FLUSHING THE OLD CIRCUIT, THE PRE-SIDE OF THE OXYGENATOR WAS COVERED IN HEMOLYTIC FIBERS, WHICH THEY ASSUMED HAD COME FROM THE PUMP HEAD. QWS BEING USED AT THIS TIME WAS SN(B)(6). CLINICAN IS ASKING US TO INVESTIGATE THIS DISPOSABLE FOR ANY POSSIBLE DEFECTS TO DETERMINE WHETHER THIS DEVELOPED IN THE PUMP HEAD OR WAS DRAWN IN FROM THE PATIENT. A VERY SIMILAR OCCURENCE WAS REPORTED ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16521305 ↗
• MalfunctionMar 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  CP22V-VT DISPOSABLE WAS CHANGED OUT DUE TO HIGH HEMOLYSIS (HIGH PLASMA FREE HEMOGLOBIN). AFTER CUTTING OUT THE OLD DISPOSABLE, IT WAS FOUND TO HAVE LARGE FIBRIN STRANDS WRAPPED IN THE FINS OF THE PUMP HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519967 ↗