Zimmon G21708Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00827002217089), received between Oct 25, 2018 and Sep 22, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23118962 ↗
• MalfunctionSep 18, 2025Material Twisted/Bent; Material Twisted/Bent

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 04-NOV-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085579 ↗
• MalfunctionSep 18, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent

  THE DOCTOR WANTED TO INSERT ZSO-7-12 INTO THE CBD THROUGH THE PREPOSITIONED (VISIGLIDE 2 0.025 STRAIGHT) WIRE GUIDE, ASSISTANT NURSE TRIED TO STRAIGHTEN THE ZSO-7-12 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-7-12 WAS USED .AND WIRE GUIDE WAS NOT CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080929 ↗
• MalfunctionAug 26, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent

  THE DOCTOR WANTED TO INSERT ZSO-7-12 INTO THE CBD THROUGH THE PREPOSITIONED (VISIGLIDE 2 0.025 STRAIGHT) WIRE GUIDE, ASSISTANT NURSE TRIED TO STRAIGHTEN THE ZSO-7-12 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-7-12 WAS USED AND WIRE GUIDE WAS NOT CHANGED..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893824 ↗
• MalfunctionAug 18, 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 26-SEP-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22836171 ↗
• MalfunctionNov 20, 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'.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9346437 ↗
• 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-7-12 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9102704 ↗
• MalfunctionMay 29, 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 Patient Involvement

  MAUDE report 8648812 ↗
• MalfunctionMay 23, 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 8636409 ↗
• 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 8586684 ↗
• MalfunctionMar 27, 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 8455087 ↗
• MalfunctionMar 25, 2019Material Deformation; Material Deformation

  BEFORE USING THIS PRODUCT FOR PROCEDURE, THE SIDE HOLE OF THIS PRODUCT PIGTAIL WAS KINK. THE WIRE GUIDE COULD NOT GET INTO THE ZSO-7-12. 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 8448687 ↗
• MalfunctionFeb 4, 2019Material Deformation; Material Deformation

  WHEN DR. (B)(6) TRIED TO INSERT ZSO, IT KINKED AND WOULDN'T COME INSIDE. SO DR. (B)(6) USED ANOTHER ZSO TO FINISH THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8300679 ↗
• 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-7-12.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8273772 ↗
• MalfunctionDec 20, 2018Material Deformation; Material Deformation

  THIS FILE 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.THE WIRE GUIDE COULD NOT GET INTO THE ZSO-7-12.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8183550 ↗
• MalfunctionDec 17, 2018Material Deformation; Material Deformation

  THIS FILE IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION PRECEDENCE "STENT KINKED/ BENT." BEFORE USING THIS PRODUCT FOR PROCEDURE, THE SIDE HOLE OF THIS PRODUCT PIGTAIL WAS KINK. THE WIRE GUIDE COULD NOT GET INTO THE ZSO-7-12.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8169156 ↗
• MalfunctionDec 14, 2018Material Deformation; Material Deformation

  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.THE WIRE GUIDE COULD NOT GET INTO THE ZSO-7-12.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8163485 ↗
• 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 8149908 ↗
• MalfunctionOct 25, 2018Material Deformation; Material Deformation

  THIS FILE IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "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; No Patient Involvement

  MAUDE report 8004833 ↗