Zimmon G22167Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00827002221673), received between May 10, 2017 and Oct 10, 2025 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (20 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2025Improper or Incorrect Procedure or Method; Dent in Material; Improper or Incorrect Procedure or Method; Dent in Material

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 07-NOV-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23270774 ↗
• MalfunctionSep 22, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 23-OCT-2025. ADDITIONAL INFO RECEIVED ON 14-OCT-2025. 1. PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. - HE KEPT THE ERCP ROOM SHADED STORAGE BOX. 2. WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? - 0.025INCH / 450CM. 3. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES. 4. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? YES. 5. WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23109700 ↗
• MalfunctionAug 21, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent

  PER REP - BEFORE USE, THEY WENT TO PUT THE WIRE THROUGH THE STENT AND COULD NOT GET IT TO GO THROUGH. THEY HAD USED THE STRAIGHTENER. THEY THEN NOTICED A KINK IN THE STENT. IT WAS AN .035 WIRE BUT THE OTHER DETAILS OF THE WIRE HAVE NOT BEEN CONFIRMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. DOES THE COMPLAINT RELATE TO: -OBSERVATION PRIOR TO PATIENT CONTACT. · DEVICE PLACEMENT, · DEVICE REMOVAL, · OBSERVATION PRIOR TO PATIENT CONTACT. IF NOT, WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? -WITH ANOTHER DEVICE OF THE SAME TYPE WHAT WAS THE TARGET LOCATION FOR THE STENT? -BILE DUCT PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. -COOL DARK ROOM *WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? -.035, OTHERWISE, UNKNOWN. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? N/A, YES, NO -WETTED WITH WATER. *WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? N/A, YES, NO* -YES. WAS THE DEVICE AT THE CENTER OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? N/A, YES, NO -YES. WERE PREVIOUS PROCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861955 ↗
• MalfunctionDec 12, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  STENTS ARE KINKING DURING THE PROCEDURE. "AS PER COMPLAINT FORM": THE PLASTIC STENT WILL BE STRAIGHTENED WITH THE STRAIGHTER, BUT BOTH STENTS ARE KINKED. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT ¿.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9457104 ↗
• MalfunctionOct 29, 2019Material Deformation; Material Deformation

  KINK IN CURLED SECTION OF STENT OCCLUDING THE LUMEN OF THE STENT- UNABLE TO THREAD ON WIRE. THIS POINT IS WEAK AND LIKELY TO BREAK WHEN IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9252134 ↗
• MalfunctionOct 21, 2019Material Deformation; Material Deformation

  WHEN THEY USED WIRE GUIDE IN TO THE ZSO-7-7 AFTER USING THE STRAIGHTENER FOR STENT WAS STRAIGHTENED WITH THE PIGTAIL, WIRE GUIDE COULD NOT INSERT IN TO THE ZSO-7-7. BECAUSE PIGTAIL WAS KINKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9213166 ↗
• MalfunctionOct 16, 2019Break; Break

  EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT FRACTURE'. THE STENT WAS REMOVED FROM ITS' PACKAGING AND IMMEDIATELY NOTED TO BE DAMAGED. IT WAS CRACKED AT THE BEGINNING OF THE CURVED AREA. IT WAS DISPOSED OF. ANOTHER ZSO-7-7 WAS OPENED AND USED FOR THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9195752 ↗
• 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. THE DOCTOR WANTED TO INSERT THE ZSO-7-7 IN THE CBD.SO THE NURSE PREPARED THE ZSO-7-7, BUT THE PIGTAIL SECTION WAS BENT AS SHE MOVED THE STENT SLEEVE TO THE PIGTAIL SECTION. SHE TRIED TO PASS THE GUIDE WIRE INTO THE ZSO-7-7, IT WAS IMPOSSIBLE, SO THEY USED THE NEW ONE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9102719 ↗
• MalfunctionSep 5, 2019Material Deformation; Material Deformation

  KINKING AT LAST HOLE WHEN LOADED ON TO THE GUIDE WIRE. "AS PER COMPLAINT FORM": STENTS REPEATEDLY KINKED ON THE WIRE EVENTUALLY THEY MANAGED TO PLACE A STENT THIS WAS A VERY EXPERIENCED NURSE ASSISTING. 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 8964900 ↗
• MalfunctionAug 19, 2019Material Deformation; Material Deformation

  KINKING AT LAST HOLE WHEN LOADED ON TO THE GUIDE WIRE. "AS PER COMPLAINT FORM": STENTS REPEATEDLY KINKED ON THE WIRE EVENTUALLY THEY MANAGED TO PLACE A STENT THIS WAS A VERY EXPERIENCED NURSE ASSISTING. 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 8906985 ↗
• MalfunctionAug 19, 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 8906984 ↗
• MalfunctionJul 29, 2019Material Deformation; Material Deformation

  WHEN THE USER STRAIGHTENED PIGTAIL WITH THE STRAIGHTENER AND ADVANCED THE STENT OVER COOK'S METRO 0.035INCH, THE STENT BECAME KINKED, THE STENT BECAME KINKED. ANOTHER ZSO-7-7 WAS USED INSTEAD. 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 8837892 ↗
• MalfunctionJul 18, 2019Material Deformation; Material Deformation

  BEFORE USING THIS PRODUCT FOR PROCEDURE, THE SIDE HOLE OF THIS PRODUCT PIGTAIL WAS KINKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8802881 ↗
• MalfunctionJul 18, 2019Material Deformation; Material Deformation

  WHEN INSERTING A PLASTIC STENT INTO THE GUIDE WIRE, THE PIGTAIL WAS KINKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8802768 ↗
• MalfunctionMay 16, 2019Material Deformation; Material Deformation

  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 8615230 ↗
• MalfunctionMay 3, 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 8577432 ↗
• MalfunctionMay 3, 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 8577330 ↗
• MalfunctionApr 17, 2019Material Deformation; Material Deformation

  UNEVEN STENT ENDS WERE OBSERVED BEFORE PRELOADING THE STENT UNTO THE PUSHING CATHETER, ONE LOOP WAS SMALLER THAN THE OTHER. THE STENT WAS THEN ATTEMPTED TO BE PRELOADED UNTO THE PUSHING CATHETER, HOWEVER IT WAS NOT ABLE TO BE PRELOADED BECAUSE THERE IS A FOLD ON THE TAPERED END OF THE STENT. 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 8522086 ↗
• MalfunctionApr 16, 2019Material Deformation; Material Deformation

  THEY TRIED TO PUT THE STENT IN THE BILE DUCT, BUT THE STENT COULD NOT PASS THROUGH THE STRICTURE IN THE BILE DUCT. 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' AND "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 8518305 ↗
• MalfunctionMar 26, 2019Material Deformation; Material Deformation

  THEY TRIED TO PUT THE STENT IN THE BILE DUCT, BUT THE STENT COULD NOT PASS THROUGH THE STRICTURE IN THE CBD. 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" AND "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 8451183 ↗
• MalfunctionMar 7, 2019Material Deformation; Material Deformation

  AS REPORTED TO CUSTOMER RELATIONS "WHEN THE STENT WAS BEING LOADED ONTO THE WIRE GUIDE, THE STENT KINKED MULTIPLE TIMES AT THE CURL AND WOULD NOT ALLOW THE WIRE GUIDE TO PASS THROUGH THE STENT. THE SLEEVE ON THE STENT WAS USED TO STRAIGHTEN THE CURL BUT THE STENT STILL 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 8398312 ↗
• 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-7-7.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8273791 ↗
• MalfunctionDec 6, 2018Material Deformation; Material Deformation

  THIS FILE IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION PRECEDENCE "STENT KINKED/ BENT" STENT KINKED; "AS PER COMPLAINT FORM": THE ASSISTANT WILL STRAIGHT THE PIGTAIL STENT WITH THE STRAIGHTER, BUT THE STENT IS KINKING

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8137554 ↗
• MalfunctionAug 14, 2018Material Deformation; Material Deformation

  THIS COMPLAINT IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION PRECEDENCE "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 Consequences Or Impact To Patient

  MAUDE report 7780373 ↗
• MalfunctionFeb 28, 2018Kinked; Kinked

  AFTER REMOVING STONES TO BILE DUCT, PHYSICIAN TRIED TO INSERT ZSO-7-7 TO DRAIN BILE JUICE AND SUSTAIN THE DUCT, BUT THE WIRE (VISIGLIDE) DIDN'T PASS THROUGH THE STENT. TIP HOLE OF THE STENT WAS TOO NARROW TO PASS THROUGH THE WIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7302331 ↗