Zimmon G21982Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002219823), received between Aug 10, 2025 and Aug 10, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (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.

• MalfunctionAug 10, 2025Off-Label Use; Off-Label Use

  OPERATOR HAD DIFFICULTY DEPLOYING STENT OVER WIRE GUIDE AND AS STENT WAS VERY STIFF AND WAS BUCKLING UNDER PRESSURE. I HAVE BEEN ADVISED BY THE DOCTOR THAT DURING A PROCEDURE ON (B)(6) 2025, THAT THE 10FR X 9MM ZIMMON STENT WAS TOO STIFF. WHEN TRYING TO STRAIGHTEN OVER STIFF GUIDEWIRE, THE STENT BUCKLES, AT RISK OF FRACTURE, RATHER THAN BEING MALLEABLE. A 7FR X 12MM ZIMMON BILIARY STENT WAS USED INSTEAD. COOK CELECT PLATINUM VENA CAVA SET FOR FEMORAL AND JUGULAR VEIN APPROACH. 1. DOES THE COMPLAINT RELATE TO DEVICE REPLACEMENT, DEVICE REMOVAL OR WAS IT AN OBSERVATION MADE PRIOR TO PATIENT CONTACT? DEVICE PLACEMENT. 2. WHAT WAS THE TARGET LOCATION FOR THE STENT? GALL BLADDER. 3. PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. AS PER IFU¿S. 4. WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? TERUMO 0.0035 STIFF WIRE GUIDE. 5. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES. 6. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? YES. 7. WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? NO. 8. WERE PREVIOUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22768299 ↗