Zimmon G22122Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002221222), received between Aug 15, 2017 and Aug 8, 2019 — 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 8, 2019Material Deformation; Material Deformation

  PRIOR TO PATIENT CONTACT, THE USER ATTEMPTED TO STRAIGHTEN THE PIG TAIL STENT (ZEBD-5-10/ C1600101) WITH THE STRAIGHTENER BUT THE STENT KINKED DURING THE ATTEMPT. ANOTHER ZEBD-5-10 WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8873510 ↗
• MalfunctionNov 15, 2018Material Deformation; Material Deformation

  THIS FILE IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION PRECEDENCE FOR "STENT KINKED/ BENT". WHEN THE PHYSICIAN ADVANCED THE STENT OVER A WIRE GUIDE WHILE STRAIGHTENING THE STENT WITH A STRAIGHTENER, HE FELT RESISTANCE. THEN, HE CONFIRMED THAT THE STENT BECAME KINKED, SO ANOTHER ZEBD-5-10/C1478264 WAS USED INSTEAD TO FINISH THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8073907 ↗
• MalfunctionAug 15, 2017Kinked; Kinked

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO UPDATE THE POTENTIAL ROOT CAUSE. WHEN STRAIGHTENING THE PIGTAIL WITH A STRAIGHTENER IN ORDER TO INSERT THE STENT INTO AN ENDOSCOPE, THE STENT KINKED. THEN, IT WAS REPLACED WITH ZEBD-6-10 AND THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6793671 ↗