SIMPULSE 0067700Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741000379), received between Feb 11, 2019 and Jun 12, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, THE SIMPULSE SOLO SUCTION/IRRIGATION DEVICE WAS LEAKING. IT WAS ALSO REPORTED THAT THE LEAKAGE OCCURRED AT THE PERFORATION IN THE TUBING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519077 ↗
• MalfunctionJun 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, THE SIMPULSE SOLO SUCTION/IRRIGATION DEVICE WAS LEAKING. IT WAS ALSO REPORTED THAT THE LEAKAGE OCCURRED AT THE PERFORATION IN THE TUBING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519076 ↗
• MalfunctionJun 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, THE SIMPULSE SOLO SUCTION/IRRIGATION DEVICE WAS LEAKING. IT WAS ALSO REPORTED THAT THE LEAKAGE OCCURRED AT THE PERFORATION IN THE TUBING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519074 ↗
• MalfunctionApr 16, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE USER FACILITY THAT WHAT WAS DESCRIBED AS GREASE WAS ALLEGEDLY SEEPING OUT FROM THE HAND PIECE OF THE SIMPULSE SOLO IRRIGATOR. THE SCRUB NURSE IDENTIFIED THE ISSUE WHEN SHE PICKED UP THE PRODUCT FOR DURING SET UP. SHE WAS ABLE TO REPLACE IT WITH A NEW ITEM TO USE IN THE CASE AND THE SUBJECT PRODUCT WAS NOT USED ON THE PATIENT. NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 8519947 ↗
• MalfunctionFeb 11, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SCRUB NURSE NOTICED WHITE RESIDUE ON THE HANDLE (TRIGGER PART) OF THE SIMPULSE SOLO SUCTION/IRRIGATOR UPON OPENING THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. THE SAMPLE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 8329121 ↗