CONMED 0031000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10653405000044), received between Mar 18, 2024 and Dec 3, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 3, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0035070, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20830988 ↗
• MalfunctionMar 18, 2024Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE 0031000, FRAZIER CONNECTING TUBING 61CM 50/CASE, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON APPROXIMATELY (B)(6) 2024 DATE WHEN IT WAS REPORTED ¿THE CLIP FELL OFF THE TUBE AND INTO THE PATIENT.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE CLIP WAS RETRIEVED FROM THE PATIENT AND NO ADVERSE EVENT OCCURRED. THE PROCEDURE WAS COMPLETED, AND IT WAS ALSO REPORTED ¿NO DELAY OR PATIENT IMPACT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924143 ↗