Quantum Perfusion Dual Lumen Cannula 27 DL27F-V0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08051160300808), received between Jan 20, 2023 and Sep 29, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON FRIDAY EVENING, CUSTOMER CALLED TO REPORT THAT EARLIER THAT DAY, THEY PLACED A PATIENT ON ECMO. THEY SELECTED THE QUANTUM 27FR DLC, BUT THEY WERE UNABLE TO FLOW. THE CUSTOMER REPORTED THAT THE CANNULA DID PRIME BACK WITH BLOOD, HOWEVER, WHEN THEY WENT TO CONNECT THE CANNULA TO THE CICUIT, THEY WERE UNABLE TO INITIATE AND ACHIEVE ANY FLOW. CUSTOMER REPORTED THAT THE ISSUE APPEARED TO BE ON THE DRAINAGE SIDE, AS THEY WERE NOT GETTING BLOOD BACK TO THE PUMP WHEN INITIATING AT 1500 RPMS OR WHEN SLOWLY INCREASING RPMS. DR. REDDY, THE CANNULATING SURGEON, HAD TO REMOVE THIS CANNULA, AND OVER WIRE TO EXCHANGE FOR A DIFFERENT ONE. THEY OPTED TO REPLACE OUR CANNULA WITH THE 29FR PROTEK DUO AND WERE ABLE TO SUCCESSFULLY DRAIN & FLOW TO THE PATIENT. THE CENTRIMAG CONSOLE AND PRECONNECTED PACK REMAINED THE SAME, THE ONLY CHANGE WAS THE CANNULA. THIS CUSTOMER DOES NOT MONITOR PRESSURES ON THEIR CENTRIMAG PACK, SO NONE TO REPORT. THE CUSTOMER DID SAVE THE CANNULA AND WOULD LIKE TO SEND IT BACK FOR INVESTIGATION. THE COORDINATOR, PERFUSIONIST AND SURGEON ALL VISUALLY INSPECTED THE CANNULA, BUT DID NOT SEE ANYTHING ABNORMAL.

  Patient problems: Insufficient Information

  MAUDE report 23166422 ↗
• MalfunctionMay 19, 2023Fracture; Fracture

  RECEIVED A CALL THAT THEY EXPERIENCE A FRACTURE TO A 27FR DUAL LUMEN CANNULA. CANNULA HAD BEEN IN FOR 7 DAYS. PATIENT ALSO HAS A HEARTMATE 3 LVAD. WITH FRACTURE OF THE CANNULA, THE SYSTEM ENTRAINED AIR. CANNULA WAS PULLED AND PATIENT PLACED ON DOBUTAMINE FOR RIGHT SIDE SUPPORT. PATIENT ADEQUATELY SUPPORTED.

  Patient problems: Air Embolism; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16960947 ↗
• MalfunctionJan 20, 2023Crack; Crack

  27FR DUAL LUMEN CANNULA NOTED TO BE LEAKING BELOW BIFURCATION OF CANNULA. PATIENT HAD BEEN ON FOR ALMOST A MONTH. CANNULA WAS REPLACED WITH ANOTHER 27FR DUAL LUMEN CANNULA WITHOUT ISSUE. POSITIVE PRESSURE MEASURING 350 ON LEAKING CANNULA. NO SUTURE WAS AT THE AREA WHERE THE CANNULA STARTING LEAKING, PERFUSIONIST SAID IT LOOKED MORE LIKE A POINT OF FLEXION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213214 ↗