Zimmon G22159Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002221598), received between Apr 25, 2018 and Aug 14, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2018Material Deformation; Material Deformation

  THIS FILE IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "STENT KINKED/ BENT". THE ZIMMON BILIARY STENT KINKED AS IT WAS BEING ADVANCED OVER THE CLEVERCUT 0.25 GUIDE WIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7780370 ↗
• MalfunctionAug 14, 2018Material Deformation; Material Deformation

  THE ZIMMON BILIARY STENT KINKED AS IT WAS BEING ADVANCED OVER THE CLEVERCUT 0.25 GUIDE WIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7780364 ↗
• MalfunctionApr 25, 2018Kinked; Kinked

  AS REPORTED TO CUSTOMER RELATIONS: "ACCORDING TO CUSTOMER, 'WIRE WOULD NOT PASS THROUGH STENT. WAS BENDING WEIRD.' NO PATIENT CONTACT, PRODUCT IS AVAILABLE FOR RETURNABLE." ADDITIONAL INFORMATION PROVIDED ON 03APR2018: "I BELIEVE THE STENT BENT WHEN TRYING TO ADVANCE OVER THE WIRE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7458119 ↗