VDW Eddy Flexcanula 21419Recalls & reported problems
Produits dentaires S.A. · Cannula Irrigation Needle - Box of 40 · Class 1
Quick summary
This VDW Eddy Flexcanula irrigation needle is used to flush and irrigate during dental, periodontal and root canal procedures. The 55 reports almost all describe the plastic irrigation tip breaking off during use, sometimes several tips at once, with 17 reports noting injuries and no deaths. No recalls name this device. Reports dropped sharply in the past 12 months, from 33 to 4.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 55
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 07640159160090), received between Jul 6, 2023 and Feb 12, 2026 — classified as 17 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Break” (55 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.
Reports received per month
Most reported problems
Device problems
- Break55
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- Insufficient Information26
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2026Break
IN THIS EVENT IT IS REPORTED THAT A EDDY TIP BROKE DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24323939 ↗MalfunctionFeb 3, 2026Break
IN THIS EVENT IT IS REPORTED THAT 3 EDDY IRRIGATION TIPS BROKE DURING USE. REPORTEDLY, NO INJURY OCCURRED. IT IS UNKNOWN HOW MANY PATIENTS ARE INVOLVED IN THIS EVENT. FURTHER INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24245109 ↗MalfunctionDec 16, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT MULTIPLE EDDY IRRIGATION TIPS OF THE SAME LOT BROKE DURING USE. FURTHER INFORMATION REQUESTED. THIS IS THE SECOND REPORT FOR THIS EVENT, AS THE FIRST REPORT HAS ALREADY BEEN SUBMITTED.
Patient problems: Insufficient Information
MAUDE report 23819051 ↗MalfunctionNov 17, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT AN EDDY IRRIGATION TIP BROKE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23567941 ↗MalfunctionJul 9, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A EDDY IRRIGATION TIP HAD BROKEN DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22458729 ↗MalfunctionJun 12, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A EDDY IRRIGATION TIP BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22196006 ↗MalfunctionJun 12, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT EDDY IRRIGATION TIPS BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22195938 ↗InjuryJun 12, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A EDDY IRRIGATION TIPS HAD BROKEN. THIS IS FOR COMPLAINT 18 OF 18. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22195885 ↗InjuryJun 12, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A EDDY IRRIGATION TIPS HAD BROKEN. THIS IS FOR COMPLAINT 17 OF 18. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22195826 ↗InjuryJun 12, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A EDDY IRRIGATION TIPS HAD BROKEN. THIS IS FOR COMPLAINT 16 OF 18. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22195800 ↗InjuryJun 12, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A EDDY IRRIGATION TIPS HAD BROKEN. THIS IS FOR COMPLAINT 15 OF 18. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22195436 ↗InjuryJun 12, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A EDDY IRRIGATION TIPS HAD BROKEN. THIS IS FOR COMPLAINT 14 OF 18. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22195410 ↗InjuryJun 12, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A EDDY IRRIGATION TIPS HAD BROKEN. THIS IS FOR COMPLAINT 13 OF 18. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22195390 ↗InjuryJun 12, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A EDDY IRRIGATION TIPS HAD BROKEN. THIS IS FOR COMPLAINT 12 OF 18. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22195389 ↗InjuryJun 12, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A EDDY IRRIGATION TIPS HAD BROKEN. THIS IS FOR COMPLAINT 11 OF 18. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22195368 ↗InjuryJun 12, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A EDDY IRRIGATION TIPS HAD BROKEN. THIS IS FOR COMPLAINT 10 OF 18. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22194991 ↗InjuryJun 12, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A EDDY IRRIGATION TIPS HAD BROKEN. THIS IS FOR COMPLAINT 9 OF 18. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22194977 ↗InjuryJun 12, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A EDDY IRRIGATION TIPS HAD BROKEN. THIS IS FOR COMPLAINT 8 OF 18. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22194935 ↗InjuryJun 12, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A EDDY IRRIGATION TIPS HAD BROKEN. THIS IS FOR COMPLAINT 7 OF 18. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22194748 ↗InjuryJun 12, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A EDDY IRRIGATION TIPS HAD BROKEN. THIS IS FOR COMPLAINT 6 OF 18. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22194734 ↗InjuryJun 12, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A EDDY IRRIGATION TIPS HAD BROKEN. THIS IS FOR COMPLAINT 5 OF 18. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22194726 ↗InjuryJun 12, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A EDDY IRRIGATION TIPS HAD BROKEN. THIS IS FOR COMPLAINT 4 OF 18. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22194647 ↗InjuryJun 12, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT AN EDDY IRRIGATION TIPS HAD BROKEN. THIS IS FOR COMPLAINT 3 OF 18. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22194630 ↗InjuryJun 12, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A EDDY IRRIGATION TIPS HAD BROKEN. THIS IS FOR COMPLAINT 2 OF 18. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22194566 ↗MalfunctionJun 3, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT EDDY IRRIGATION TIP BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22132179 ↗
Other Syringe, Periodontic, Endodontic, Irrigating devices
- Maxi-probe Irrigation Needle MAXP301TTulsa Dental Products LLC · SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING9 reports
- Henry Schein 5701403Henry Schein, Inc. · SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING1 report
- Henry Schein 5701401Henry Schein, Inc. · SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING1 report
- Monoject 1180327114ECardinal Health, Inc. · SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.