Endo-Flo 0037970Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741065217), received between Nov 11, 2020 and Apr 28, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE BARD/DAVOL ENDO-FLO IRRIGATOR LEAKED IRRIGATION FLUID WHEN CONNECTED TO THE LUER-LOCK OF THE NON-BARD/DAVOL METAL HANDPIECE. AS REPORTED, CONNECTOR DID NOT SEAL AND IT APPEARED "LIKE THE THREADS ARE OF THE WRONG PATTERN". THERE WAS NO REPORTED PATIENT INJURY. REPORTER STATED "THE TUBING DOES NOT LEAK WITH DISPOSABLE INSTRUMENTS. IT ONLY LEAKS WITH THE METAL INSTRUMENT. IT DOES NOT LEAK WHEN CONNECTING TO A PLASTIC CONNECTOR. WHEN ATTACHING THE TUBING TO THE METAL IRRIGATION INSTRUMENT, THERE IS SIGNIFICANT LEAKAGE AT THE CONNECTOR. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14238065 ↗
• MalfunctionApr 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING A GALLBLADDER REPAIR PROCEDURE ON (B)(6) 2022, THE BARD/DAVOL ENDO-FLO IRRIGATOR LEAKED IRRIGATION FLUID WHEN USED WITH A REUSABLE NON-BARD/DAVOL TRUMPET VALVE. THERE WAS NO REPORTED PATIENT INJURY. REPORTER STATED "THE TUBING DOES NOT LEAK WITH DISPOSABLE INSTRUMENTS. IT ONLY LEAKS WITH THE METAL INSTRUMENT. IT DOES NOT LEAK WHEN CONNECTING TO A PLASTIC CONNECTOR. WHEN ATTACHING THE TUBING TO THE METAL IRRIGATION INSTRUMENT, THERE IS SIGNIFICANT LEAKAGE AT THE CONNECTOR. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14234435 ↗
• MalfunctionApr 19, 2022Fluid/Blood Leak; Material Separation; Gas/Air Leak; Fluid/Blood Leak; Material Separation; Gas/Air Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE BARD/DAVOL ENDO-FLO IRRIGATOR LEAKED IRRIGATION FLUID FROM THE BIFURCATION. ALSO REPORTED WAS AN AIR LEAK AT THE SAME POSITION. AS REPORTED THE JOINT SEAL WAS LOOSE, BUT THERE WERE NO DETACHED PIECES. AS REPORTED, THE PRESSURE AT WHICH THE DEVICE WAS OPERATED IS UNKNOWN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141569 ↗
• MalfunctionFeb 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED ON (B)(6) 2021, THE BARD/DAVOL ENDO-FLO IRRIGATOR LEAKED SALINE NEAR THE DIAPHRAGM DURING FLUSHING. AS REPORTED, PERFUSED WATER WAS FLOWING AT THE TIME OF PREPARATION FOR USE, AND WATER LEAKED FROM THE VICINITY OF THE DIAPHRAGM, AND USE WAS STOPPED AT THAT POINT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 11324060 ↗
• MalfunctionNov 11, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, ON (B)(6) 2020, THE ENDO-FLO IRRIGATOR LEAKED SALINE FROM THE DEVICE DURING PRIMING. AS REPORTED, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PIECES FOUND DETACHED FROM THE DEVICE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10822193 ↗