Zimmon G21637Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002216372), received between Dec 5, 2017 and Jun 27, 2019 — classified as 5 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 27, 2019Material Deformation; Material Deformation

  KINK/DENT ON STENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8738765 ↗
• MalfunctionFeb 13, 2019Material Deformation; Material Deformation

  STENT BROKE ONE SIDE WHILE BEING THREADED ONTO 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 8337634 ↗
• MalfunctionOct 10, 2018Material Deformation; Material Deformation

  THIS FILE IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION PRECEDENCE ¿STENT KINKED/ BENT'. HE WAS A CBD STRICTURE PATIENT. WHEN DR. (B)(6) PASSED STRICTURE USING ZSO 10FR, THE TIP WAS KINKED. AND THERE WAS NO POSITIONING SLEEVE IN THE PACKAGE. SO DR. (B)(6) USED CLSO 10FR. IN ORDER TO FINISH THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7952023 ↗
• MalfunctionAug 13, 2018Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  THIS COMPLAINT IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "DIFFICULT ADVANCEMENT" AND "STENT KINKED/ BENT" AS PER (B)(4) TRANSLATION: THE INNER LUMEN OF THE STENT IS "TOO" SMALL. AS PER CC FORM: THE ZIMMON STENT HAVE NOT ENOUGH SPACE FOR A WIREGUIDE THE JAGWIRE GUIDEWIRE IS IN THE BILIARY DUCT. FIRST THE TAKE A GUIDING CATHETER OVER THE GUIDE WIRE, AFTER THAN SHE WILL THE ZIMMON STENT WITH A PUSHER OVER THE GUIDING CATHETER INTO THE SCOPE, BUT IT ISN'T POSSIBLE, "THEN" SHE TAKE THE GUIDING CATHETER OUT AND PUSH THE ZIMMON STENT WITH THE PUSHER OVER THE WIREGUIDE, IT ISN´T ALSO POSSIBLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7776088 ↗
• MalfunctionDec 5, 2017Difficult to Advance; Difficult to Advance

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO DEVICE RETURN AND EVALUATION. DR (B)(6) LAL COMPLAINED THAT THIS PARTICULAR ZSO WAS VERY STIFF, HE WAS NOT ABLE TO PLACE THE STENT EVEN THOUGH THE TRACK WAS WELL DILATED. HE COMPLAINED THAT THE PRODUCTS WAS NOT UP TO THE MARK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7082030 ↗