Zimmon G22980Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002229808), received between Mar 13, 2017 and Jan 22, 2020 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  USER REMOVE THE STONE BY CHOLANGIOTOMY AND IMPLANT THE STENT IN PANCREAS AS DRAINAGE PURPOSE. PATIENT HAD RECURRENT VOMITING, ABDOMINAL PAIN, JAUNDICE 3 DAYS AFTER STENT IMPLANTATION. USER TOOK SOME TREATMENT TO RELIEVE THE SYMPTOM BUT FAILED. USER REMOVE THE STENT BY GASTROSCOPE AND THE ABDOMINAL PAIN AND JAUNDICE IS RELIEVED GRADUALLY. USER INVESTIGATE THE CASE AND CONCLUDE THE REASON IS PATIENT RELATED, AND PATIENT HAD REJECTION REACTION AGAINST STENT.

  Patient problems: Jaundice

  MAUDE report 9615597 ↗
• MalfunctionSep 12, 2019Use of Device Problem; Material Deformation; Use of Device Problem; 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 9009978 ↗
• MalfunctionApr 25, 2019Material Deformation; Material Deformation

  THE SINGLE PIGTAIL WAS KINKED WHEN THE PLASTIC STENT WAS INSERTED INTO THE GUIDE WIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8550531 ↗
• MalfunctionSep 25, 2018Material Deformation; Material Deformation

  THE DEVICE WAS EVALUATED ON THE (B)(6) 2018 CONFIRMING THE STENT FLAPS WERE MISSING, THIS COMPLAINT IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION OF "STENT FRACTURE" THEY TRIED TO PUT THE SPSOF-5-5 IN AN PANCREATIC DUCT, BUT THE STENT COULD NOT PASS THROUGH THE STRICTURE IN THE PANCREATIC DUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7904933 ↗
• MalfunctionAug 16, 2018Material Deformation; Material Deformation

  THIS COMPLAINT IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "STENT FRACTURE". USER CHECKED THE INTEGRITY OF THE DEVICE BEFORE USE AND FOUND OUT THERE IS AN OBVIOUS BREACH AT THE DISTAL END OF THE DEVICE. USER DIDN'T USE THE DEVICE AND CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7788579 ↗
• MalfunctionMar 13, 2017Fracture; Fracture

  AS REPORTED TO CUSTOMER RELATIONS: "THE NURSE STRAIGHTEN THE STENT IN-ORDER TO ASSEMBLE IT ON THE GUIDE WIRE AND WHILE STRAIGHTENING THE STENT BROKE. THE NURSE REPLACE IN A NEW ONE AND IT HAPPENED AGAIN." RELATED TO REPORT # 3001845648-2017-00092.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6399111 ↗
• MalfunctionMar 13, 2017Fracture; Fracture

  AS REPORTED TO CUSTOMER RELATIONS: "THE NURSE STRAIGHTEN THE STENT IN-ORDER TO ASSEMBLE IT ON THE GUIDE WIRE AND WHILE STRAIGHTENING THE STENT BROKE. THE NURSE REPLACE IN A NEW ONE AND IT HAPPENED AGAIN." RELATED TO REPORT # 3001845648-2017-00093.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6398925 ↗