Zimmon G24592Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002245921), received between Jul 26, 2017 and Jul 26, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2017Fracture; Fracture

  AS REPORTED TO CUSTOMER RELATIONS, "THE STENT WAS BROKEN (ALMOST COMPLETELY SEVERED) WHEN IT CAME OUT OF THE PACKAGE. IT WAS NEVER USED IN THE PATIENT. THEY WOULD LIKE A REPLACEMENT." ADDITIONAL INFORMATION RECEIVED BY THE DM ON 05JULY2017 AFTER HOURS: AFTER SPEAKING WITH THE ACCOUNT, I WOULD LIKE TO ADD THE FOLLOWING TO MY DESCRIPTION. THE NURSE REMOVED THE STENT FROM THE PACKAGE AND DID ADVANCE THE STENT OVER A COOK METII-21-480 WIRE GUIDE. (ORIGINALLY, I THOUGHT IT BROKE WHEN REMOVED FROM THE PACKAGE). WHEN THE STENT WAS ALMOST AT THE BIOPSY PORT OF THE SCOPE, THE NURSE NOTICED THAT THE STENT HAD BROKEN. THEY REMOVED THE STENT, TOOK THE PICTURE FOR ME AND THEN FINISHED THE CASE SUCCESSFULLY WITH ANOTHER OF THE SAME COOK STENT. THE STENT DID NOT GO INTO THE SCOPE BUT THE PIGTAIL WAS STRAIGHTENED TO BE ABLE TO PUSH THE STENT OVER THE WIRE (APPROX. 300CM). THIS ACCOUNT USES MANY OF THESE SINGLE PIGTAIL STENTS SO THEY ARE AWARE OF HOW TO STRAIGHTEN THE PIGTAIL CAREFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6743445 ↗