FLEXITIP 000216Recalls & reported problems
Conmed Corporation · CONMED FLEXITIP DISPOSABLE SCLEROTHERAPY NEEDLE, OPTIC YELLOW FLEXITIP NEEDLE, 5 MM X 160 CM, 25 GM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30653405051163), received between Feb 15, 2022 and Feb 15, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (1 report).
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
Device problems
- Failure to Advance1
Patient problems
- Abdominal Pain1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 15, 2022Failure to Advance
ADULT FEMALE WITH HISTORY OF LIVER CIRRHOSIS D/T ALCOHOL ABUSE. ADMITTED TO ICU DUE TO RECENT ABDOMINAL PAIN WITH N/V AND BLOODY STOOLS. PROCEDURE: EGD WITH CHIP PLACEMENT. SCLEROTHERAPY NEEDLE PRIMED AND FUNCTIONED NORMALLY WHEN TESTED. WHEN IT WAS BEING USED DURING THE PROCEDURE, THE NEEDLE WOULD NOT ADVANCE. ANOTHER NEEDLE OBTAIN AND USED TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, WHEN THE 1ST NEEDLE WAS INSPECTED, THE NEEDLE STILL WOULD NOT ADVANCE. NO KNOWN HARM TO PATIENT, MINOR DELAY IN PROCEDURE. MANUFACTURER RESPONSE FOR NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE, CONMED FLEXITIP (PER SITE REPORTER) WILL OBTAIN.
Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13534206 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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