Zimmon G21393Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00827002213937), received between Aug 16, 2017 and Oct 28, 2025 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (14 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 10 DEC 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401789 ↗
• MalfunctionDec 31, 2019Break; Crack; Material Twisted/Bent; Break; Crack; Material Twisted/Bent

  SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS. INITIAL REPORT DETAILS: DAMAGE LIKE A CRACK NEXT TO A HOLE AT THE ONE SIDE OF THE PIG TAILS WAS FOUND. UPDATED ON DEC 16TH BY (B)(6). WHEN THE PHYSICIAN WAS ABOUT TO USE THE PRODUCT, DAMAGE LIKE A CRACK NEXT TO A HOLE AT THE ONE SIDE OF THE PIG TAILS WAS FOUND PRIOR TO USE. ANOTHER ZEBD-7-4 WAS USED TO COMPLETE THE PROCEDURE INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9535525 ↗
• MalfunctionDec 12, 2019Material Deformation; Material Deformation

  THE DEVICE WAS SCHEDULED TO BE USED FOR BILIARY STENT PLACEMENT. BEFORE THE PATIENT CONTACT, THE PHYSICIAN STRAIGHTENED PIGTAIL CURL WITH THE PIGTAIL STRAIGHTENER. THEN, THE PIGTAIL CURL BECAME KINKED. THEREFORE, ANOTHER PRODUCT WAS USED INSTEAD TO COMPLETE THE PROCEDURE. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/ BENT'.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9458371 ↗
• MalfunctionNov 26, 2019Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  WHEN THE DOCTOR ATTEMPTED TO PASS THE STENT THROUGH THE WIRE GUIDE, THE INSERTION WAS VERY HARD TO BE CONDUCTED. THEREFORE, THE PROCEDURE WAS COMPLETED WITH A SUBSTITUTE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9376057 ↗
• MalfunctionNov 20, 2019Material Deformation; Material Deformation

  THE DEVICE WAS USED FOR ERBD. THE PHYSICIAN USED THE DEVICE FOLLOWING THE IFU. HE STRAIGHTENED THE STENT BY STRAIGHTENER AND ATTEMPTED TO ADVANCE IT, BUT IT BECAME KINKED (ADDITIONAL FILE). ALSO, A WIRE GUIDE PROTRUDED FROM THE GUTTER. IT WAS IMPOSSIBLE TO CONTINUE TO USE THE STENT. THEREFORE, THE SUBSTITUTE STENT WAS USED AS TO CONTINUE THE PROCEDURE. THIS STENT WAS ALSO KINKED, BUT THE DEGREE OF KINK WAS LIGHT (THIS FILE). FINALLY, THE SUBSTITUTE STENT WAS PLACED IN THE BILE DUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9346419 ↗
• MalfunctionNov 20, 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¿. THE DEVICE WAS USED FOR ERBD. THE PHYSICIAN USED THE DEVICE FOLLOWING THE IFU. HE STRAIGHTENED THE STENT BY STRAIGHTENER AND ATTEMPTED TO ADVANCE IT, BUT IT BECAME KINKED. ALSO, A WIRE GUIDE PROTRUDED FROM THE GUTTER. IT WAS IMPOSSIBLE TO CONTINUE TO USE THE STENT. THEREFORE, THE SUBSTITUTE STENT WAS USED AS TO CONTINUE THE PROCEDURE. THIS STENT WAS ALSO KINKED, BUT THE DEGREE OF KINK WAS LIGHT. FINALLY, THE SUBSTITUTE STENT WAS PLACED IN THE BILE DUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9346406 ↗
• MalfunctionSep 24, 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'. THE USER STRAIGHTEN THE STENT (ZEBD-7-4/ LOT C1610920) WITH HIS HAND AND STARTED ADVANCING THE STENT OVER OLYMPUS'S VISIGLIDE2 0.025 WIRE GUIDE BUT IT KINKED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9108632 ↗
• MalfunctionAug 15, 2019Material Deformation; Material Deformation

  PRIOR TO PATIENT CONTACT, THE USER STRAIGHTENED THE PIG TAIL STENT WITH THE STRAIGHTENER AND HE FOUND A KINK ON THE STENT. THE CUSTOMER DISPOSED THE DEVICE AND COMPETITOR'S 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 8897031 ↗
• MalfunctionAug 7, 2019Material Deformation; Material Deformation

  AFTER STRAIGHTENING THE PIGTAIL WITH THE STRAIGHTENER, THE USER ADVANCED THE STENT OVER ANOTHER MANUFACTURER'S WIRE GUIDE, BUT FAILED. THEN, KINK IN THE PIGTAIL WAS CONFIRMED, SO ANOTHER ZEBD-7-4 (LOT# UNKNOWN) 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 8868281 ↗
• MalfunctionJul 25, 2019Material Deformation; Material Deformation

  DRAINAGE CATHETER PLACEMENT WAS PERFORMED TO TREAT DISTAL BILE DUCT STENOSIS AND THE USER OPENED PACKAGING OF ZEBD-7-4/LOT C1308385. THE USER STRAIGHTENED THE STENT WITH THE STRAIGHTNTER AND ATTEMPTED TO ADVANCE THE STENT OVER OLYMPUS'S VISIGLIDE 0.025" BUT THE WIRE DID NOT PASS THROUGH THE STENT. THE USER CHECKED THE STENT AND FOUND A KINK ON IT. ANOTHER DEVICE WAS USED INSTEAD. THERE HAVE BEEN NO ADCVESE 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¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8825902 ↗
• MalfunctionJul 24, 2019Material Deformation; Material Deformation

  THE USER STRAIGHTENED THE PIG TAIL USING THE STRAIGHTENER AND ADVANCED IT OVER A WIRE GUIDE (SIZE UNKNOWN). RESISTANCE WAS MET DURING ADVANCEMENT BUT HE CONTINUED ADVANCING IT. WHEN THE STENT CAME OUT OF THE ENDOSCOPE TIP, HE FOUND THERE WAS A KINK IN THE PIG TAIL PART. HE THOUGHT THE KINKED PART COULD BREAK WHEN REMOVING, SO HE DECIDED NOT TO PLACE IT IN THE BILE DUCT. SO HE DROP THE STENT IN THE STOMACH AND REMOVED IT FROM THE PATIENT'S BODY. THEN ANOTHER STENT WAS PLACED WITH NO PROBLEM AND THE PROCEDURE WAS COMPLETED. 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¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8822099 ↗
• MalfunctionApr 12, 2019Material Deformation; Material Deformation

  THE STENT KINKED WHILE THE USER WAS STRAIGHTENING IT USING THE STRAIGHTENER. HE REPLACED IT WITH ANOTHER STENT 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 8507662 ↗
• MalfunctionJan 10, 2019Material Deformation; Material Deformation

  IMPOSSIBLE TO PASS THROUGH THE STENT, THE END OF THE WIRE IS DAMAGED AND DO NOT GET BACK TO ITS NORMAL POSITION. DEVICE AVAILABLE: 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 8234779 ↗
• MalfunctionOct 25, 2018Material Deformation; Material Deformation

  WHEN THE USER STRAIGHTENED PIGTAIL WITH THE STRAIGHTENER AND ADVANCED THE STENT OVER OLYMPUS'S 0.025INCH WIRE GUIDE (VISISHOT 2), THE STENT BECAME KINKED. THEREFORE, ANOTHER ZEBD-7-4 WAS USED INSTEAD. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8005014 ↗
• MalfunctionOct 1, 2018Material Deformation; Material Deformation

  THIS FILE IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "STENT KINKED/ BENT" THE PHYSICIAN ATTEMPTED TO ADVANCE THE STENT OVER OLYMPUS'S WIRE GUIDE (VISIGLIDE 0.025 INCH ANGLE) WITH A STRAIGHTENER THOUGH, THE WIRE GUIDE COULD NOT TRANSIT THROUGH THE STENT DUE TO A KINK/KINKS IN THE STENT. THEREFORE, ANOTHER DEVICE WAS USED INSTEAD. (THE OPERATING ROOM WAS DARK, BUT THE PROCEDURE WAS CONDUCTED AS USUAL.) THERE HAVE BEEN NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7922268 ↗
• MalfunctionJul 19, 2018Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  REPORT IS BEING SUBMITTED UNDER THE REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DIFFICULT ADVANCEMENT¿. THE USER STRAIGHTENED THE PIG TAIL OF THE STENT USING THE STRAIGHTENER AND ATTEMPTED TO ADVANCE IT OVER AN OLYMPUS VISIGLIDE 2 WIRE GUIDE. HOWEVER THE WIRE GUIDE TIP PENETRATED THE STENT. HE REPLACED IT WITH ANOTHER STENT TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7702784 ↗
• MalfunctionMay 10, 2018Kinked; Kinked

  DURING AN ATTEMPT OF ADVANCING THE STENT OVER A WIRE GUIDE, THE PIGTAIL PART GOT KINKED. THEN, ANOTHER DEVICE WAS USED INSTEAD. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. REPORTING BASED ON PRECEDENCE FOR THE ISSUE OF "STENT KINKED/BENT". FOLLOW UP SUBMITTED TO UPDATE INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7502683 ↗
• MalfunctionMay 2, 2018Kinked; Kinked

  THE PIG TAIL OF THE STENT KINKED EASILY WHEN THE CUSTOMER STRAIGHTENED THE PIG TAIL USING THE STRAIGHTENER. THE DIFFERENT DEVICE WAS USED FOR THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7478874 ↗
• MalfunctionApr 17, 2018Kinked; Kinked

  STENT WAS NOT FITTED ON PATIENT AS THERE WAS A WEAKNESS ON THE LUGS (ERGOTS). STENT DISCARDED. CONSIGNMENT: 1 UNIT. CUSTOMER WANTS A REPLACEMENT. "AS PER COMPLAINT FORM": THERE WAS A WEAKNESS ON THE FLAP WITH IMPOSSIBILITY TO PASS A GUIDE WIRE THE STENT HAS APPLICATION. THEY TAKE ANOTHER STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7435474 ↗
• MalfunctionMar 22, 2018Kinked; Kinked

  A (B)(6) YEAR OLD LADY PATIENT, HAD A PROCEDURE FOR A FISTULA ON GASTROSTOMY SLEEVE. AT THE BEGINNING OF THE PROCEDURE, THE STENT FOLDED IN ITS PACKAGING AND STAFF COULD NOT UNFOLD IT. A NEW STENT WAS USED. THE CUSTOMER WANTS A SAMSON BOX, OR THE DEVICE WILL BE DESTROYED. CUSTOMER REQUESTS A FREE REPLACEMENT OR A CREDIT NOTE. LOT NUMBER TO BE CONFIRMED BY CUST, AS CUST WROTE LOT C142921 ON ENCLOSE DOCUMENT. I TOOK THE LOT THAT CORRESPONDS THE MOST. "AS PER COMPLAINT FORM": THE NURSE SAYS THE STENT WAS KINKED IN THE PACKAGE; REPORTING BASED ON KINK PRECEDENCE FOR THIS DEVICE FAMILY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7361675 ↗
• MalfunctionNov 20, 2017Bent; Kinked; Bent; Kinked

  ENDOSCOPIC BILE DUCT STENT PLACEMENT WAS PERFORMED. THE USER STRAIGHTEN THE PIGTAIL WITH THE STRAIGHTER, THEN ADVANCED OVER THE WIRE GUIDE (BOSTON SCIENTIFIC/ JAGWIRE 0.035 INCH) BUT IT GOT KINKED AND WOULD NOT ADVANCED OVER THE WIRE GUIDE. THEREFORE, THE DEVICE WAS CHANGED WITH ANOTHER ZEBD-7-4/ LOT# UNKNOWN, AND THE PROCEDURE WAS FINISHED WITH THE REPLACEMENT DEVICE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7045015 ↗
• MalfunctionOct 12, 2017Difficult to Advance; Difficult to Advance

  THIS FOLLOW UP MDR IS BEING SUBMITTED TO INCLUDE AN UPDATE TO THE DEVICE EVALUATION AND INVESTIGATION CONCLUSIONS. INITIAL REPORT DETAILS: THOUGH THE PHYCICIAN ATTEMPTED TO INSERT THE STENT OVER A WIRE GUIDE, THE STENT WOULD NOT ADVANCE OVER IT, THEN THE WIRE GUIDE PERFORATED THE STENT. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. <ADDITIONAL INFORMATION PROVIDED ON 19/SEP/2017> THOUGH THE PHYCICIAN ATTEMPTED TO INSERT THE STENT OVER A WIRE GUIDE, THE STENT WOULD NOT ADVANCE OVER IT, THEN THE WIRE GUIDE PERFORATED THE STENT. ANOTHER DEVICE WAS USED INSTEAD, AND THE PROCEDURE WAS COMPLETED. THE PATIENT RECOVERED ON THE (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6943398 ↗
• MalfunctionSep 28, 2017Bent; Kinked; Bent; Kinked

  THIS FOLLOW UP MDR IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. THE PRODUCT HAS NOT BEEN USED BECAUSE IT WAS BENT. PRODUCT NOT AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6900351 ↗
• MalfunctionAug 16, 2017Kinked; Kinked

  THIS REPORT FORMS PART OF A RETROSPECTIVE REVIEW OF OPEN COMPLAINTS FOR A NEW MALFUNCTION PRECEDENCE FOR THIS DEVICE FAMILY ESTABLISHED ON 18-JUL-2017: 'STENT KINKED/BENT'. THE USER STRAIGHTENED THE PIG TAIL OF THE STENT USING THE STRAIGHTENER AND ATTEMPTED TO ADVANCE IT OVER A WIRE GUIDE (OLYMPUS' VISIGLIDE 0.025INCH), BUT FAILED. HE FOUND A KINK ON THE PIG TAIL AND REPLACED IT WITH ANOTHER ONE WITH THE SAME LOT# TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6796939 ↗