Zimmon G22164Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002221642), received between May 8, 2019 and Jan 29, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2020Material Twisted/Bent; Material Twisted/Bent

  WHEN THEY USED WIRE GUIDE IN TO THE ZSO-7-6 AFTER USING THE STRAIGHTENER FOR STENT WAS STRAIGHTENED WITH THE PIGTAIL, WIRE GUIDE COULD NOT INSERT IN TO THE ZSO-7-6. BECAUSE PIGTAIL WAS KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9642463 ↗
• 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'. WHEN THEY USED WIRE GUIDE IN TO THE ZSO-7-6 AFTER USING THE STRAIGHTENER FOR STENT WAS STRAIGHTENED WITH THE PIGTAIL, WIRE GUIDE COULD NOT INSERT IN TO THE ZSO-7-6. BEACUASE PIGTAIL WAS KINKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9165123 ↗
• MalfunctionSep 18, 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-7-6 AFTER USING THE STRAIGHTENER FOR STENT WAS STRAIGHTENED WITH THE PIGTAIL, WIRE GUIDE COULD NOT INSERT IN TO THE ZSO-7-6. BECAUSE PIGTAIL WAS KINKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9081817 ↗
• MalfunctionAug 12, 2019Difficult to Advance; Difficult to Advance

  EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DIFFICULT ADVANCEMENT'. THEY TRIED TO PUT THE WIRE GUIDE IN THE ZSO-7-6 FOR PLACE THE STENT IN THE BILE DUCT, BUT THE WIRE GUIDE COULD NOT PASS THROUGH IN THE ZSO-7-6.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8882581 ↗
• MalfunctionMay 8, 2019Material Deformation; Material Deformation

  THEY TRIED TO PUT THE WIRE GUIDE IN THE ZSO-7-6 FOR PLACE THE STENT IN THE BILE DUCT, BUT THE WIRE GUIDE COULD NOT PASS THROUGH IN THE ZSO-7-6. 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' AND ¿DIFFICULT ADVANCEMENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8591430 ↗