Zimmon G21707Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00827002217072), received between Jan 19, 2017 and Oct 10, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23270821 ↗
• MalfunctionAug 26, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent

  THE DOCTOR WANTED TO INSERT ZSO-7-10 INTO THE CBD THROUGH THE PREPOSITIONED (VISIGLIDE 2 0.025 STRAIGHT) WIRE GUIDE, ASSISTANT NURSE TRIED TO STRAIGHTEN THE ZSO-7-10 USING A STRAIGHTENER. THE NURSE STRAIGHTENED ZSO'S PIGTAIL AND PASSED A WIRE THROUGH, BUT THE WIRE DID NOT PASS. THE WIRE DID NOT PASS BECAUSE THE PIGTAIL WAS BENT. THE NEW ZSO-7-10 WAS USED .AND WIRE GUIDE WAS NOT CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893552 ↗
• MalfunctionJan 30, 2020Difficult to Advance; Difficult to Advance

  BEFORE USING THIS PRODUCT FOR PROCEDURE, THE SIDE HOLE OF THIS PRODUCT PIGTAIL WAS KINK. THEY COULDN'T PASS THE WIRE GUIDE IN TO THE ZSO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9647396 ↗
• MalfunctionOct 8, 2019Material Deformation; Material Deformation

  EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿ STENT KINKED/BENT¿. BEFORE USING THIS PRODUCT FOR PROCEDURE, THE SIDE HOLE OF THIS PRODUCT PIGTAIL WAS KINK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9165124 ↗
• MalfunctionSep 26, 2019Material Deformation; Material Deformation

  EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT'. THE DOCTOR WANTED TO INSERT THE ZSO-7-10 IN THE CBD. SO THE NURSE PREPARED THE ZSO-7-10, BUT 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-7-10, IT WAS IMPOSSIBLE, SO THEY USED THE NEW ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9121878 ↗
• MalfunctionSep 11, 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 8992525 ↗
• MalfunctionMay 13, 2019Failure to Advance; Failure to Advance

  "WHEN THEY TRIED TO USE THE ZSO-7-10, THE WIRE GUIDE COULD NOT ADVANCE IN TO THE ZSO-7-10. THEY SAID THAT THE ZSO-7-10 INNER HOLE WAS BLOCKED." FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DIFFICULT ADVANCEMENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8603114 ↗
• MalfunctionApr 25, 2019Material Deformation; Material Deformation

  USER FOUND OUT THE PIGTAIL END KINK BEFORE USE. NO USE ON PATIENT. USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. 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 8550579 ↗
• MalfunctionApr 19, 2019Material Deformation; Material Deformation

  BEFORE USING THIS PRODUCT FOR PROCEDURE, THE SIDE HOLE OF THIS PRODUCT PIGTAIL WAS KINK. SO, THEY CUOLDN'T PASS THE WIRE GUIDE IN TO THE ZSO. 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 Patient Involvement

  MAUDE report 8530960 ↗
• MalfunctionJan 24, 2019Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  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'. BEFORE USING THIS PRODUCT FOR PROCEDURE, THE SIDE HOLE OF THIS PRODUCT PIGTAIL WAS "KINK". THE WIRE GUIDE COULD NOT GET INTO THE ZSO-7-10.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8273793 ↗
• MalfunctionDec 11, 2018Difficult to Advance; Difficult to Advance

  THIS FILE IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION PRECEDENCE "DIFFICULT ADVANCEMENT." THEY TRIED TO PUT THE STENT IN THE BILE DUCT, BUT THE STENT COULD NOT PASS THROUGH THE STRICTURE IN THE CHD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8149910 ↗
• MalfunctionJan 31, 2018Kinked; Kinked

  INITIAL MDR SUBMITTED BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT¿ WHEN THEY TRY TO USE THE ZSO-7-10, THE WIRE GUIDE CAN'T ADVANCE IN TO THE ZSO-7-10. THEY SAID THAT THE ZSO-7-10 INNER HOLE WAS BLOCKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7230077 ↗
• InjuryMay 10, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  THEY WERE ABLE TO CONFIRM THE STENT MIGRATION IMMEDIATELY AFTER PLACEMENT OF THE STENT.SO THEY REMOVED MIGRATION STENT.

  Patient problems: No Code Available

  MAUDE report 6557000 ↗
• MalfunctionJan 19, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  AFTER CONFIRMING THE OCCURRENCE OF CBD STRICTURE, THE ZSO STENT IS MOUNTED ON THE RIGHT AND LEFT HILAR, RESPECTIVELY, AND THE PROCEDURE IS TERMINATED. THE STENT WAS FOUND TO BE DISAPPEARED DURING FOLLOW UP CHECK-UP ONE MONTH AFTER PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6263044 ↗
• MalfunctionJan 19, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  AFTER CONFIRMING THE OCCURRENCE OF CBD STRICTURE, THE ZSO STENT IS MOUNTED ON THE RIGHT AND LEFT HILAR, RESPECTIVELY, AND THE PROCEDURE IS TERMINATED. THE STENT WAS FOUND TO BE DISAPPEARED DURING FOLLOW UP CHECK-UP ONE MONTH AFTER PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6263043 ↗