Zimmon G21526Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002215269), received between Apr 25, 2018 and Aug 21, 2019 — classified as 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2019Material Deformation; Material Deformation

  THE USER STRAIGHTENED THE STENT WITH A STRAIGHTENER SLOWLY, THEN ATTEMPTED TO ADVANCE IT OVER A WIRE GUIDE. HOWEVER, THE STENT COULD NOT ADVANCE OVER THE WIRE GUIDE DUE TO A KINK IN THE PIGTAIL. ANOTHER ZEBD-7-12 WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. 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 8915868 ↗
• MalfunctionMay 16, 2019Material Deformation; Material Deformation

  AFTER PLACING OLYMPUS'S WIRE GUIDE "VISIGLIDE 0.025INCH" IN THE B6 AREA, THE PHYSICIAN STRAIGHTENED THE STENT WITH THE STRAIGHTENER IN ORDER TO ADVANCE THE STENT OVER THE WIRE GUIDE. HOWEVER, BECAUSE THE WIRE GUIDE COULD NOT PASS THROUGH THE STENT DUE TO KINK, ANOTHER STENT WAS USED INSTEAD. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. 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 8615231 ↗
• MalfunctionMay 13, 2019Material Deformation; Material Deformation

  THE USER STRAIGHTENED THE PIG TAIL (ZEBD-7-12/ LOT C1554025) USING THE STRAIGHTENER AND ATTEMPTED TO ADVANCE IT OVER A WIRE GUIDE (M-THROUGH 0.025 ANGLE TIP / ASAHI INTECC) BUT THE WIRE GUIDE WOULD NOT PASS THROUGH THE STENT LUMEN. HE FOUND THERE WAS A KINK IN THE PIG TAIL AND REPLACED IT WITH ANOTHER ZEBD-7-12 TO COMPLETE THE PROCEDURE. 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 8603031 ↗
• MalfunctionJan 9, 2019Material Deformation; Material Deformation

  THE STENT KINKED WHEN THE USER WAS STRAIGHTENING THE PIG TAIL USING THE STRAIGHTENER. ANOTHER DEVICE WAS USED INSTEAD FOR THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8230215 ↗
• MalfunctionJun 14, 2018Break; Kinked; Break; Kinked

  THE USER STRAIGHTENED THE PIG TAIL OF THE STENT USING THE STRAIGHTENER AND ATTEMPTED TO ADVANCE IT OVER A WIRE GUIDE (OLYMPUS' VISIGLIDE ANGLED 0.025 INCH) THAT WAS PLACED IN THE HEPATIC PORTAL REGION. BUT THE WIRE GUIDE WOULD NOT BE INSERTED INTO THE STENT LUMEN DUE TO A KINK OF THE PIG TAIL. HE REPLACED IT WITH ANOTHER ZEBD-7-12 TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7600740 ↗
• MalfunctionApr 25, 2018Kinked; Kinked

  UPON OPENING THE PACKAGE, THE USER FOUND THAT THE STENT WAS KINKED ALREADY. HE USED ANOTHER ZEBD-7-12 FOR THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7458342 ↗