Endo-Flo 0043950Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741065231), received between Oct 1, 2020 and Jul 23, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2021, THE BARD/DAVOL TRUMPET VALVE & PROBE TIP DEVICE LEAKED WATER AT THE CONNECTION OF THE PROBE WITH THE ASPIRATOR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12219303 ↗
• MalfunctionOct 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, WHILE USING THE ENDO-FLO IRRIGATOR WITH TRUMPET VALVE & PROBE TIP DEVICE ON (B)(6) 2020, WATER LEAKED FROM THE TUBE OF THE PROBE, BETWEEN THE ENDO-FLO AND THE HANDLE, PRIOR TO USE ON THE PATIENT. THERE WAS NO REPORTED PATIENT OR USER INJURY. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10613667 ↗