DLP® 10534Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20613994685982), received between Apr 12, 2024 and Apr 12, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP ¿Y¿ TYPE VENTING ADAPTER, IT WAS REPORTED THAT THE ONE WAY VALVE IN THE DEVICE WAS NOT WORKING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT TYPICALLY, DURING BYPASS, THE PERFUSIONIST FLUSHES CARDIOPLEGIA SOLUTION THROUGH THE CARDIOPLEGIA DEVICE AND LINE TO THE TABLE, THEN TO THE CARDIOPLEGIA WYE (RETURNED), AND FINALLY BACK TO THE PUMP VIA THE VENT LINE. THE VENT INCLUDES A GRAVITY LOOP, SO WHEN CARDIOPLEGIA IS FLUSHED, THERE IS MINIMAL RESISTANCE UNLESS THE SURGEON HAS ACCIDENTALLY CLAMPED THE WYE SOMEWHERE. DESPITE FLUSHING THE CARDIOPLEGIA, LITTLE TO NO SOLUTION PASSED THE ONE-WAY VALVE IN THE CARDIOPLEGIA WYE. THE TEAM CHECKED THEIR CLAMPS, FINDING ONLY ONE ON THE CARDIOPLEGIA CANNULA, AS REQUIRED TO PREVENT SOLUTION OR AIR FROM REACHING THE PATIENT BEFORE APPLYING THE CROSS CLAMP. WHEN HIGH LINE PRESSURES WERE DETECTED BACK AT THE PUMP, THE CUSTOMER REPORTED THIS. NO OBVIOUS MECHANICAL FAULT WAS FOUND IN THE LINE, SO THE TEAM OPTED TO REPLACE THE WYE. THE SECOND WYE DIDN'T PRESENT ANY ISSUES, AND NO OTHER COMPONENTS WERE CHANGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095362 ↗