Venus Bulk Flow ONE 66094723Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI J014660947230), received between Oct 8, 2024 and Oct 10, 2024 — classified as 2 injuries.

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

• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MANUFACTURER AWARENESS DATE OF REPORTABILITY: 18.09.2024. A DENTIST INFORMED KULZER CUSTOMER SERVICE THAT A FEMALE PATIENT (64 YEARS OLD, TREATED HYPERTENSION, WITH A HISTORY OF SMOKING) COMPLAINED ABOUT ONGOING SYMPTOMS OF DISCOMFORT AND MORE DIFFICULT BREATHING DEVELOPED AT HOME IN THE EVENING AFTER A FILLING TREATMENT. THE DENTIST WAS INFORMED ABOUT THE SYMPTOMS FROM THE PATIENT ON DAY 4 AFTER THE TREATMENT. THE PATIENT IS ALLERGIC TO NICKEL, WHICH IS NOT ADDED TO THE PRODUCTS. PATIENT HAS PROBABLY BEEN PRONE TO ALLERGIES FOR A WHILE (ONE YEAR). THE DENTIST POINTED OUT THAT IT WAS VERY HOT ON THE DAY OF THE TREATMENT. A ROOT CANAL-TREATED TOOTH (37) WAS TREATED FOR THE REPLACING OF AN AMALGAM FILLING. THE TOOTH PROGNOSIS AT THIS DATE IS UNKNOWN. WE ARE THEREFORE UNABLE TO ASSESS WHY THE PATIENT WANTS THE TOOTH EXTRACTED. ON (B)(6) 2024 THE DENTIST INFORMED THAT THE TOOTH HAS BEEN EXTRACTED BY AN ORAL SURGEON AT THE PATIENT'S REQUEST. THE CAUSE (MEDICAL INDICATION) FOR THE EXTRACTION IS UNKNOWN. THE DENTIST SUSPECTS THAT THE SYMPTOMS HAVE NOT BEEN DUE TO THE FILLING RATHER TO THE OUTSIDE HEAT. NEVERTHELESS AN ALLERGY TESTING HAS BEEN RECOMMENDED, WHICH THE PATIENT REFUSED.

  Patient problems: Tooth Loss

  MAUDE report 20415039 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MANUFACTURER AWARENESS DATE OF REPORTABILITY: 18.09.2024. A DENTIST INFORMED KULZER CUSTOMER SERVICE THAT A FEMALE PATIENT (64 YEARS OLD, TREATED HYPERTENSION, WITH A HISTORY OF SMOKING) COMPLAINED ABOUT ONGOING SYMPTOMS OF DISCOMFORT AND MORE DIFFICULT BREATHING DEVELOPED AT HOME IN THE EVENING AFTER A FILLING TREATMENT. THE DENTIST WAS INFORMED ABOUT THE SYMPTOMS FROM THE PATIENT ON DAY 4 AFTER THE TREATMENT. THE PATIENT IS ALLERGIC TO NICKEL, WHICH IS NOT ADDED TO THE PRODUCTS. PATIENT HAS PROBABLY BEEN PRONE TO ALLERGIES FOR A WHILE (ONE YEAR). THE DENTIST POINTED OUT THAT IT WAS VERY HOT ON THE DAY OF THE TREATMENT. A ROOT CANAL-TREATED TOOTH (37) WAS TREATED FOR THE REPLACING OF AN AMALGAM FILLING. THE TOOTH PROGNOSIS AT THIS DATE IS UNKNOWN. WE ARE THEREFORE UNABLE TO ASSESS WHY THE PATIENT WANTS THE TOOTH EXTRACTED. ON (B)(6) 2024, THE DENTIST INFORMED THAT THE TOOTH HAS BEEN EXTRACTED BY AN ORAL SURGEON AT THE PATIENT'S REQUEST. THE CAUSE (MEDICAL INDICATION) FOR THE EXTRACTION IS UNKNOWN. THE DENTIST SUSPECTS THAT THE SYMPTOMS HAVE NOT BEEN DUE TO THE FILLING RATHER TO THE OUTSIDE HEAT. NEVERTHELESS AN ALLERGY TESTING HAS BEEN RECOMMENDED, WHICH THE PATIENT REFUSED.

  Patient problems: Tooth Loss

  MAUDE report 20398824 ↗