Zimmon G22161Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002221611), received between Sep 12, 2017 and Jan 15, 2020 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2020Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent

  AS PER SOURCE DOC: STENTS KINKED BEFORE ADVANCING OVER THE WIRE. AS PER COMPLAINT FORM: MR (B)(6) WAS PLANNING TO PLACE 2 DOUBLE PIGTAIL STENTS FOR A PATIENT WITH MULTIPLE CBD STONES. WHEN ATTEMPTING TO STRAIGHTEN THE STENTS BEFORE PLACING OVER THE WIRE IT WAS NOTED THAT BOTH KINKED VERY EASILY AND WERE UNUSABLE. THE PROCEDURE WAS COMPLETED WITH FURTHER ZSO-7-4 STENTS. AS PER ADDITIONAL QUESTIONS: 1.1.1 WHAT IS THE REORDER NUMBER OF THE WIRE GUIDE USED WITH THIS DEVICE? BSC JAGWIRE 1.1.2 IF NOT, WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? FURTHER ZSO-7-4 STENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9590244 ↗
• MalfunctionAug 22, 2019Material Deformation; Material Deformation

  THE DOCTOR WANTED TO INSERT THE ZSO-7-4 IN TO THE CBD, DURING THE PROCESS OF PASSING THE STENT THROUGH THE WIRE, THE PART OF THE PIG TAIL WAS FOLDED. SO THE WIRE DID NOT PASS AND SHE HAD TO USE ANOTHER 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 8919625 ↗
• MalfunctionMay 3, 2019Material Deformation; Material Deformation

  THE STENT IS NOT BEING ABLE TO PASS ONTO THE WIRE DUE TO ONE OF THE HOLES SPLITTING THE STENT SO GUIDE WIRE DOES NOT PASS THROUGH. "AS PER CC FORM" THE STENT IS NOT BEING ABLE TO PASS ONTO THE WIRE DUE TO ONE OF THE HOLES SPLITTING THE STENT SO GUIDE WIRE DOES NOT PASS THROUGH. COMPLETED THE PROCEDURE USING ANOTHER 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 8577421 ↗
• MalfunctionMar 19, 2019Material Deformation; Material Deformation

  WHEN THEY ARE STRAIGHTENING THE STENT A WIRE WILL NOT PASS THROUGH FREELY DUE TO KINKS IN THE STENT. THEY ARE NOT SURE IF THE WHOLE BATCH IS AFFECTED "AS PER COMPLAINT FORM": WHEN STRAIGHTENING THE STENT A WIRE WILL NOT PASS THROUGH FREELY DUE TO KINKS IN STENT. THIS IS THE SECOND TIME WITH THIS TYPE OF STENT THIS HAS OCCURRED. UNFORTUNATELY THE FIRST ONE WAS DISCARDED, WE ARE NOT SURE IF THE WHOLE BATCH IS AFFECTED : ZIMMON BILIARY STENT, REF ZSO-7-4, LOT NO. C1546479. WE HAVE THE FAULTY ONE IN THE OFFICE IF YOU REQUIRE IT RETURNED TO BE EXAMINED. 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 8431470 ↗
• MalfunctionMar 11, 2019Material Deformation; Material Deformation

  STENT KINKED WHEN BEING PUT ON THE WIRE. 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 8408013 ↗
• 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-7-4.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8273773 ↗
• 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 8137564 ↗
• MalfunctionMar 21, 2018Kinked; Kinked

  AS REPORTED TO CUSTOMER RELATIONS: "A ZIMMON BILIARY STENT (G22161) WAS BEING PREPARED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. DEVICE WAS REMOVED FROM THE PACKAGING AND WHILE ATTEMPTING TO LOAD THE STENT KINKED. ANOTHER OF THE SAME WAS USED TO CONTINUE WITH THE PROCEDURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7357635 ↗
• MalfunctionSep 12, 2017Bent; Bent

  STENT TAKEN FROM PACKAGE AND VISUALLY INSPECTED BEFORE OUT ONTO THE WIRE, NURSE AND MYSELF NOTICED SLIGHT INDENTATION ON ONE OF THE DRAINAGE HOLES ON THE PIGTAIL. STENT STRAIGHTENED USING STRAIGHTENER AND WIRE WOULD NOT ADVANCE, WHEN REMOVED WHERE THE INDENTATION HAD BEEN THERE WAS NOW A KINK. I CAN SAY THIS IS NOT A TRAINING ISSUE, STENT WAS CLEARLY WEAK IN THAT POINT BEFORE STRAIGHTENED. THE DEVICE DID NOT ENTER PATIENT, ONLY ATTEMPTED TO PUT ON END OF WIRE. NO PATIENT CONTACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6857319 ↗