Zimmon G22170Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002221703), received between Jan 19, 2017 and Sep 17, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent

  WHEN THE NURSE USED THE STRAIGHTENER TO STRAIGHTEN THE STENT, THE STENT WAS KINK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076156 ↗
• MalfunctionJan 9, 2020Material Twisted/Bent; Material Twisted/Bent

  BEFORE USING THIS PRODUCT FOR PROCEDURE, THE SIDE HOLE OF THIS PRODUCT PIGTAIL WAS KINK ¿STENT KINKED/ BENT'.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9568429 ↗
• MalfunctionDec 24, 2019Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  THE DOCTOR WANTED TO INSERT THE ZSO-7-12 IN THE LEFT HEPATIC DUCT. SO THE NURSE PREPARED THE ZSO-7-12, AND THE PIGTAIL SECTION WAS BENT AS SHE MOVED THE STENT SLEEVE TO THE PIGTAIL SECTION. SHE TRIED TO PASS THE GIUIDE WIRE INTO THE ZSO-7-12, IT WAS IMPOSSIBLE EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/ BENT' AND 'DIFFICULT ADVANCEMENT'.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9516345 ↗
• MalfunctionSep 10, 2019Material Deformation; Material Deformation

  BEFORE USING THIS PRODUCT FOR PROCEDURE, THE SIDE HOLE OF THIS PRODUCT PIGTAIL WAS KINK 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 8984285 ↗
• MalfunctionSep 10, 2019Material Deformation; Material Deformation

  BEFORE USING THIS PRODUCT FOR PROCEDURE, THE SIDE HOLE OF THIS PRODUCT PIGTAIL WAS KINK. 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 8984244 ↗
• MalfunctionMay 7, 2019Material Deformation; Material Deformation

  WHEN INSERTING A PLASTIC STENT INTO THE GUIDE WIRE, THE PIGTAIL WAS KINKED. 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 8586681 ↗
• MalfunctionAug 14, 2018Material Deformation; Material Deformation

  THIS COMPLAINT IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE OF "STENT KINKED/ BENT". AS REPORTED TO CUSTOMER RELATIONS: "DEVICES APPEARED KINKED IN THE PIGTAIL. SAME PLACE IN EACH STENT...DM CONFIRMED SOME SORT OF KINK. OCCURRED WHEN PREPARING DEVICES, SO COULD HAVE BEEN USER-RELATED. IT'S ON THE PROXIMAL PIGTAIL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7780363 ↗
• InjuryJun 8, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: THE CUSTOMER REPORTED THE FOLLOWING COMPLAINT ISSUE; "THEY FOUND THE BENT AT PIGTAIL PART AFTER THEY HAD FINISHED PROCEDURE, SO THEY REMOVED PLASTIC STENT OUT OF ENDOSCOPE." HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED ON THE 12 MAY 2017 CONFIRMING THAT "THEY USED ALLIGATOR FORCEP FOR THE MIGRATION STENT REMOVED" AND ON 01 JUNE 2017 IT WAS FURTHER CONFIRMED ¿THEY COMPLAINT POINT IS THE MIGRATION AFTER PROCEDURE DOING WELL. IT¿S NOT POINT TO BEND AT THE PIGTAIL.¿ THEREFORE, UPON THIS INFORMATION, THIS COMPLAINT IS REFERRING TO STENT MIGRATION RATHER THAN A BEND AT THE PIGTAIL.

  Patient problems: Foreign Body In Patient

  MAUDE report 6621241 ↗
• InjuryJan 19, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  STENT MIGRATED AND WAS PULLED OUT ONE DAY AFTER THE PROCEDURE. IT WAS DETECTED BY X-RAY. THE PROCEDURE WAS NORMAL. THE STONE WHICH WAS IN CBD REMOVED AND ZSO WAS ON THE RIGHT HILAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6263041 ↗