Quantum Perfusion Dual Lumen Cannula 31F DL31F-V0Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08051160300792), received between Feb 22, 2022 and Jul 3, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 reports).

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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(6), PLACED THEIR FIRST CANNULA (31FR) ON SATURDAY. CANNULA DISLODGED WHILE TRYING TO REMOVE THE OBTURATOR. DURING SECOND ATTEMPT COULD NOT REMOVE OBTURATOR. SMALL KINK IN RV. CLINICIAN STATED PATIENT WENT TO CT FOR POSSIBLE RV WALL INJURY AND BRONCHIAL ARTERIAL BLEED. CANNULA STILL IN USE, WILL REQUEST RETURN ONCE THE CANNULA IS REMOVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22392355 ↗
• InjuryNov 22, 2024Deformation Due to Compressive Stress; Insufficient Device Problem Information; Deformation Due to Compressive Stress; Insufficient Device Problem Information

  A CANNULA GO THROUGH THE RV OF A PATIENT. THIS CANNULA WAS PLACED 7 DAYS PRIOR WITH NO ISSUES. ON INSERTION A SMALL KINK WAS NOTICED AT THE INSERTION SITE, I INFORMED THEM TO TAKE DOWN THE SUTURE AND RESECURE AS THERE WAS LIKELY TOO MUCH FORWARD PRESSURE ON THE CANNULA. 7 DAYS LATER, THE CANNULA KINKED INTERNALLY AND PUSHED THROUGH THE RV FREE WALL, REQUIRING THE PATIENT TO GO TO SURGERY. THE CANNULA WAS REMOVED AND THE HOLE WAS REPAIRED. THE PATIENT WAS THEN PLACED ON ANOTHER DEVICE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 20755721 ↗
• MalfunctionSep 5, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PT SUPPORTED ON VV ECMO WITH A DLCA SINCE 1/31. THE TEAM REPORTED AN EVENT TODAY 5/19 WHERE THE CANNULA SEPARATED AT THE VENOUS Y. THEY ATTEMPTED TO TIE BAND THE CONNECTION BUT WERE UNABLE TO SECURE AND SO THE PATIENT WAS RECANNULATED TO VA ECMO. PATIENT WELFARE INFORMATION - OFF ECMO - RECEIVED A BILATERAL LUNG TRANSPLANT.

  Patient problems: Air Embolism

  MAUDE report 15354950 ↗
• MalfunctionJun 10, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  QUANTUM DUAL LUMEN VENOUS. "I JUST WANTED TO BRING TO YOUR ATTENTION AN ISSUE WE HAD TODAY WITH A SPECTRUM CANNULA. ONE OF OUR CURRENT PATIENTS, BEGAN ENTRAINING AIR FROM THE VENOUS SIDE IF THE NECK OR CANNULA WERE MANIPULATED IN ANY WAY. WE EXCHANGED THE CANNULA IN THE OPERATING ROOM AND THE ATTACHED VIDEO IS OF THE SPECTRUM CANNULA ONCE IT WAS REMOVED FROM THE PATIENT."

  Patient problems: Air Embolism

  MAUDE report 14653110 ↗
• MalfunctionMay 26, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2022 IT WAS REPORTED THAT THERE WAS THRILL HEARD BY THE PATIENT COMING FROM THE 31 FR DL CANNULA. THE THRILL WAS OCCURRING DURING MANIPULATION OF THE CANNULA. SMALL AMOUNT MICRO-BUBBLES WERE OBSERVED ENTRAINING INTO THE CIRCUIT. NO ACTIONS WERE MADE BY THE TEAM AT THIS POINT OF THE EVENING AND DECIDED TO SUPPORT THE CANNULA THROUGH THE NIGHT. ON (B)(6) 2022 UPON MY ARRIVAL AT THE HOSPITAL, THE PATIENT WAS TAKEN ELECTIVELY TO THE OR FOR CANNULA EXCHANGE. THE EXCHANGE HAPPENED WITHOUT ISSUES. OF NOTE: 1. CANNULA HAS BEEN IN PLACE FOR 47 DAYS WITHOUT MANIPULATION. CANNULATION (B)(6) 2022 AT 14:08. 2. THE PATIENT HAS BEEN AMBULATING FOR SEVERAL WEEKS. 3. NO ALCOHOL WAS USED PER STANDARD CARE PROCEDURES (CHG APPLICATORS). CANNULA NOTES: 1. PER XXXXXX XXXXX, AT SITE OF ISSUE, SUTURES WERE USED TO HOLD CANNULA. 2. NO HEPARIN WAS USED ON PATIENT. 3. LARGE CLOTS NOTED IN RV PORTS. 4. TIP OF CANNULA CUT PER INSTITUTIONAL PREFERENCE.

  Patient problems: Air Embolism

  MAUDE report 14516865 ↗
• MalfunctionMay 9, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS PLACE ON ECMO WITH THE CANNULA IN QUESTION, ESTIMATED DATE IS (B)(6) 2022. THE NURSE MANAGER FOR THEIR ECMO ICU UNIT NOTIFIED ME THAT THEIR 31 FR DUAL LUMEN CANNULA "DE COUPLED" WHILE ON A PATIENT. THE PATIENT WAS SITTING UP IN BED WHEN THIS HAPPENED. THE DRAINAGE HUB OF THE DUAL LUMEN CANNULA CAME UNDONE AND DISCONNECTED FROM THE CANNULA. THE ECMO CIRCUIT FILLED WITH AIR. THE ECMO SPECIALIST WERE VERY QUICK TO REACT AND CLAMPED THE CIRCUIT. THE PATIENT WAS VERY STABLE DURING THIS TIME. THEY WERE ABLE TO RE CANNULATE THE PATIENT WITH A DIFFERENT CANNULA. THE PATIENT IS DOING WELL ON ECMO NOW AND NOTED NO SIGNIFICANT BLOOD LOSS OR SIGNIFICANT CLINICAL DEFICIENCIES.

  Patient problems: Air Embolism

  MAUDE report 14335282 ↗
• MalfunctionFeb 22, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  31FR QUANTUM DUAL LUMEN CANNULA WAS IN PLACE ON A PATIENT PROVIDING SUPPORT. THE CANNULA BECAME DECOUPLED OUTSIDE OF THE PATIENT, NEAR THE "METAL FINGERS" WHERE THE WIRE REINFORCEMENT AREA STOPS. THE PATIENT WAS RESUSCITATED ON VA ECMO SUPPORT AND PHYISCIAN REPORTED THAT THE PATIENT APPEARS TO BE INTACT. HOSPITAL IS PERFORMING INTERNAL RISK MANAGEMENT PROCESS, THEN THE DEVICE WOULD BE AVAILABLE FOR CUSTOMER RETURN.

  Patient problems: Air Embolism

  MAUDE report 13575707 ↗