Malecot G16923Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002169234), received between Aug 7, 2017 and Aug 7, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2017Break; Break

  A COOK EMPLOYEE WAS PERFORMING RESEARCH AND FOUND THE FOLLOWING REPORT IN THE MAUDE DATABASE. "PT WAS ADMITTED TO THE SURGERY CENTER FOR EXAM UNDER ANESTHESIA. MD DETERMINED THAT THERE WAS AN ANAL FISTULA, FISTULOTOMY PERFORMED, MD REQUESTED SILICONE MALECOT CATHETER FOR PLACEMENT, TO BE REMOVED BY MD AT A LATER DATE. CENTER WAS NOTIFIED BY THE MD THAT DURING REMOVAL OF THE CATHETER, THE TIP BROKE OFF AND WAS LEFT IN THE PT. THE TIP OF THE CATHETER HAD TO BE SURGICALLY REMOVED. THE CENTER'S PURCHASING COORDINATOR NOTIFIED QA MANAGER AND CONTACTED THE PRODUCT MFR/REP. ALL OTHER SILICONE MALECOT CATHETERS REMOVED FROM STOCK AT THIS TIME. MD NOTIFIED SURGERY CENTER OF EVENT THE WEEK OF THE EVENT." FOLLOW-UP FOR FURTHER EVENT/PATIENT DETAILS COULD NOT BE PERFORMED. THE IDENTITIES OF THE REPORTER AND THE MENTIONED MD WERE NOT PROVIDED IN THE MAUDE ADVERSE EVENT REPORT. A SEARCH OF COMPLAINT HISTORY RECORDS WAS UNABLE TO LOCATE ANY RECORD SHOWING THIS EVENT WAS PREVIOUSLY REPORTED TO COOK INCORPORATED.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6772621 ↗