Zimmon G22163Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002221635), received between Dec 29, 2017 and Aug 5, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent

  DESCRIPTION OF EVENT: THE NURSE WAS PREPARING TO USE THE ZSO-7-5 AND HAD JUST OPENED THE PACKAGING OF THE NEW ZSO-7-5. WHILE STRAIGHTENING THE PIGTAIL WITH A STRAIGHTENER, THE PIGTAIL BENT, AND THE WIRE COULD NO LONGER GO IN. THEREFORE, THEY HAD TO USE A NEW ZSO-7-5. PATIENT/EVENT INFO - NOTES. RECEIVED INFO - 22-JUL-2025. 1. WHAT WAS THE TARGET LOCATION FOR THE STENT? CBD. 2. PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. THE PRODUCT IS STORED IN A CART DRAWER THAT DOES NOT ALLOW SUNLIGHT TO PASS THROUGH. 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 CENTER OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? YES. 6. DID THE PATIENT INVOLVED EXHIBIT ALTERED ANATOMY OR TORTUOUS ANATOMY? N/A. 7. WHETHER THEY USED THE PIGTAIL PROVIDED WITH THE DEVICE? THE STRAIGHTENER PROVIDED WITH THE DEVICE WAS USED. 8. WERE ANY PREPARATORY STEPS PERFORMED TO THE DEVICE (PER INSTRUCTIONS FOR USE, IF APPLICABLE) PRIOR TO NOTICING THE DAMAGE? IF SO, PLEASE DESCRIBE HOW THE DEVICE WAS PREPARED: THEY PREPARED ACCORDING TO THE PROCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713857 ↗
• 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-7-5 IN THE CBD. SO THE NURSE PREPARED THE ZSO-7-5, 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-7-5, 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 9102720 ↗
• MalfunctionSep 17, 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 THEY USE PIGTAIL STRAIGHTENER,THE SIDE HOLE OF THIS PRODUCT PIGTAIL WAS KINK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9075971 ↗
• MalfunctionAug 7, 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 8868510 ↗
• MalfunctionJul 31, 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 8847329 ↗
• MalfunctionMay 28, 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 8646280 ↗
• MalfunctionMay 13, 2019Material Deformation; Material Deformation

  UPON OPENING THE STENTS THEY FOUND INDENTS ON THE 2 STENTS. THEY DID NOT USE ON THE PATIENT BOTH PRODUCTS AVAILABLE FOR RETURN INSPECTION. AS PER COMPLAINT FORM: "MR (B)(6) OPENED BOTH STENTS TO NOTICE THEY "WERE" KINKED. UPON TRY TO PLACE THEM OVER THE WIRE HE NOTED DIFFICULTY AND REPLACED WITH NEW DEVICES ZSO DEVICES." 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 8603088 ↗
• 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-7-5.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8273794 ↗
• MalfunctionJul 27, 2018Retraction Problem; Material Deformation; Retraction Problem; Material Deformation

  DOCTOR REMOVED THE STONE FROM THE CBD. BUT STONE REMAINED IN CYSTIC DUCT. HE WAS CONCERNED THAT THE STONE OF THE CYSTIC DUCT WOULD COME DOWN TO THE BILE DUCT, BLOCKING THE WAY. SO HE WANTED TO INSERT ZSO-7-5 INTO THE CBD. WHILE THE NURSE TRIED TO INSERT THE GUIDE WIRE INTO THE STENT, PIGTAIL OF STENT WAS FOLDED. SO GUIDE WIRE COULD NOT PASS THE STENT. THE NEW ZSO-7-5 WAS USED FOR THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7726086 ↗
• MalfunctionApr 24, 2018Difficult to Advance; Difficult to Advance

  AFTER THE STONE EXTRACTION PROCEDURE, THE PHYSICIAN TRIED TO INSERT ERBD TO DRAIN COMMON BILE DUCT. WHEN THE WIRE PASSED THROUGH THE ZSO-7-5, THE "PIGTAIL" PART CURVED IRREGULARLY. (MAYBE IT WAS BROKEN).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7455460 ↗
• MalfunctionMar 26, 2018Kinked; Kinked

  AFTER THE STONE EXTRACTION PROCEDURE, THE PHYSICIAN TRIED TO INSERT ERBD TO DRAIN COMMON BILE DUCT. WHEN THE WIRE PASSED THROUGH THE ZSO-7-5, THE PIGTAI PART CURVED IRREGULARLY. (MAY BE IT WAS BROKEN).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7369695 ↗
• MalfunctionDec 29, 2017Difficult to Advance; Difficult to Advance

  THIS FOLLOW UP MDR IS BEING SUBMITTED TO UPDATE THE INVESTIGATION CONCLUSIONS. THE BILE DUCT WAS CANNULATED ROUTINELY HOWEVER THE CUSTOMER WAS UNABLE TO PUSH THE GUIDE WIRE THROUGH THE STENT IN ORDER TO MOUNT IT ON THE WIRE. THE STENT COULD NOT BE MOUNTED IN THE WIRE GUIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7153790 ↗