Zimmon G21711Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002217119), received between Mar 5, 2018 and Oct 10, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Dent in Material” (3 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. How this data works · Data updated Oct 13, 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.

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

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 06-NOV-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23270859 ↗
• MalfunctionJul 25, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE DOCTOR WANTED TO INSERT THE ZSO-7-15 INTO THE LEFT IHD. FOLLOWING THE ALREADY POSITIONED VISIGLIDE 2 STRAIGHT 0.025" WIRE, THE ZSO-7-15 WAS LOADED AND PUSHED WITH THE PC-7. THE ZSO-7-15 ENTERED THE CBD, BUT WHILE POSITIONING IT IN THE DESIRED LOCATION, THE ZSO-7-15 COULD NOT BE PUSHED FURTHER, AND EVEN PULLING THE GUIDE WIRE DID NOT SEPARATE THE WIRE. DESPITE APPLYING FORCE, IT DID NOT COME OUT, SO THE ENTIRE SCOPE WAS REMOVED. THE WIRE AND STENT WERE TANGLED AND COULD NOT BE SEPARATED, SO THE WIRE WAS CUT TO REMOVE THE STENT. THE SCOPE WAS REINSERTED, AND A NEW VISIGLIDE 2 STRAIGHT 0.025" GUIDE WIRE WAS PLACED, FOLLOWED BY THE INSERTION OF ENBD-7 TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22620651 ↗
• MalfunctionJul 24, 2025Improper or Incorrect Procedure or Method; Dent in Material; Improper or Incorrect Procedure or Method; Dent in Material

  DURING THE LOADING PROCESS ONTO ZSO-7-15 ON THE GUIDE WIRE (0.025" VISIGLIDE, STRAIGHT), THE PIGTAIL PART OF THE STENT WAS BENT. THE WIRE DID NOT PASS THE STENT, THEY FINISHED THE PROCESS USING THE NEW ZSO-7-15, AND THE GUIDE WIRE WAS NOT REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586030 ↗
• MalfunctionOct 29, 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'. REPORTED BY THE DM VIA PHONE CALL WHILE TRYING TO PUT THE STENT ONTO THE GUIDEWIRE, THE PIG TAIL GOT KINKED. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9252171 ↗
• MalfunctionSep 23, 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¿. WHEN THEY USED WIRE GUIDE IN TO THE ZSO-7-15 AFTER USING THE STRAIGHTENER FOR STENT WAS STRAIGHTENED WITH THE PIGTAIL, WIRE GUIDE COULD NOT INSERT IN TO THE ZSO-7-15. BEACUASE PIGTAIL WAS KINKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9102688 ↗
• MalfunctionDec 11, 2018Difficult to Advance; Difficult to Advance

  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 8149900 ↗
• MalfunctionSep 14, 2018Difficult to Advance; Difficult to Advance

  THIS COMPLAINT IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION PRECEDENCE "DIFFICULT ADVANCEMENT." THEY TRIED TO PUT THE ZSO-7-15 IN TO THE INTRAHEPATIC DUCT, BUT THE ZSO-7-15 COULD NOT PASS THROUGH THE STRICTURE IN THE INTRAHEPATIC DUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7875933 ↗
• MalfunctionAug 27, 2018Dent in Material; Material Deformation; Dent in Material; Material Deformation

  REPORT IS BEING SUBMITTED UNDER THE PRECEDENCE OF "STENT KINKED". BEFORE USING THIS PRODUCT FOR PROCEDURE, THE SIDE HOLE OF THIS PRODUCT PIGTAIL WAS KINK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818356 ↗
• MalfunctionMar 5, 2018Kinked; Kinked

  AFTER REMOVING STONES TO BILE DUCT, PHYSICIAN TRIED TO INSERT ZSO-7-15 TO DRAIN BILE JUICE AND SUSTAIN THE DUCT, WIRE PASSED THROUGH THE PIGTAIL TIP BUT STUCK TO THE END OF THE PIGTAIL PART. THE PIGTAIL CURVED IRREGULARLY. (MAYBE BROKEN)

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7313107 ↗