VENUS FLOW SYR 1 x 1,8G - A3 66014565Recalls & reported problems
Kulzer GmbH · Dental Composite resin · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI J014660145650), received between Nov 21, 2023 and Nov 21, 2023 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Headache1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT CLAIMS THAT SHE SUFFERS FROM HEADACHE, AMNESIC APHASIA, FORGETFULNESS, SHAKING, AND STOMACH ISSUES AFTER A VENUS FLOW COMPOSITE FILLING WAS PLACED. SHE HAS SEEN 3 NEUROLOGISTS, HAD AN MRT, A GASTROSCOPY AND BLOOD DRAWN. NOTHING WAS FOUND DURING THESE EXAMINATIONS. THEREFORE, SHE EXPECTS THAT THE SYMPTOMS ARE CAUSED FROM VENUS FLOW FILLING. NO FEEDBACK HAS BEEN PROVIDED FROM THE TREATING DENTIST AFTER MULTIPLE ATTEMPTS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Headache
MAUDE report 18180280 ↗
Other MATERIAL, TOOTH SHADE, RESIN devices
- G-CAM GC00138Graphenano Dental Sl. · Material, Tooth Shade, Resin1 recall0 reports
- G-CAM GC00092Graphenano Dental Sl. · Material, Tooth Shade, Resin1 recall0 reports
- Transcend 4817-Ultradent Products, Inc. · MATERIAL, TOOTH SHADE, RESIN1 recall0 reports
- G-CAM GC00112Graphenano Dental Sl. · Material, Tooth Shade, Resin1 recall0 reports
- G-CAM GC00117Graphenano Dental Sl. · Material, Tooth Shade, Resin1 recall0 reports
- G-CAM GC00115Graphenano Dental Sl. · Material, Tooth Shade, Resin1 recall0 reports
- G-CAM GC00094Graphenano Dental Sl. · Material, Tooth Shade, Resin1 recall0 reports
- G-CAM GC00130Graphenano Dental Sl. · Material, Tooth Shade, Resin1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page