Zilver 635 G50622Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10827002506227), received between Jun 20, 2016 and Jun 2, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Dent in Material

  THROUGH THE ENDOSCOPIC CHANNEL, THE STENT WAS GUIDED ALONG THE ACRO WIRE GUIDE TO THE COMMON BILE DUCT. AFTER A LONG EFFORT, IT WAS UNABLE TO CROSS THE STENOSIS AREA. USER RETRACTED THE DEVICE FROM PATIENT, IT WAS FOUND THAT THE TIP OF THE STENT WAS BENT AND UNUSABLE. DURING THE CLEANING PROCESS, THE STENT WAS ACCIDENTALLY RELEASED, AND THE KINK INSIDE THE STENT WERE CLEARLY VISIBLE. SUCCESSFULLY COMPLETED THE PROCEDURE BY CHANGING TO ANOTHER SAME RPN DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25358719 ↗
• MalfunctionJan 11, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  USER PLANNED TO PLACE 2 STENTS IN PATIENT. USER PLACED 2 WIRE GUIDE RESPECTIVELY IN LEFT AND RIGHT HEPATIC DUCT, THEN OPENED THE DEVICE PACKAGE AND INJECT WATER, THEN ADVANCED THE DELIVERY SYSTEM THROUGH WIRE GUIDE IN ENDOSCOPY WHILE USER DETECTED THE WHITE TIP OF DELIVERY SYSTEM MISSING. USER THEN RETRACTED THE DELIVERY SYSTEM AND CHANGED TO ANOTHER PRODUCT FROM SAME LOT# BUT OPENED THE PACKAGE FOUND OUT THE WHITE TIP MISSING AS WELL. USER THEN CHANGED TO BOSTON SCIENTIFIC SIMILAR DEVICE TO COMPLETE THE PROCEDURE. "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE." ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO. WAS BALLOON DILATION PERFORMED PRIOR TO USE OF THE STENT DEVICE? YES. WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? 2CM LONG, 3 DIAMETER. WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? NO. WHAT WAS THE POSITION OF THE ELEVATOR DURING DEPLOYMENT? CLOSED. WAS THE DELIVERY SYSTEM TRACKED AROUND A TIGHT ANGLE IN THE PATIENT ANATOMY OR AROUND A TIGHT ANGLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13224393 ↗
• MalfunctionSep 3, 2021Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  DEVICE EVALUATED ON 14-OCT-21: "STENT STRUT PROTRUDING THROUGH OUTER SHEATH. COILED SECTION OF OUTER SHEATH SEPARATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421825 ↗
• MalfunctionAug 17, 2020Material Deformation; Material Deformation

  SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO THE INVESTIGATION BEING COMPLETED ON 16-MAR-2021. AFTER THEY PLACE WHOLE DEVICE INTO THE PLACE AND THEY TRY TO DEPLOY THE DEVICE AND THEY CANNOT DEPLOY, SO THEY CHANGE A NEW ONE.

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

  MAUDE report 10417662 ↗
• MalfunctionSep 11, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  USER ADVANCED THE DEVICE THROUGH ENDOSCOPY BUT FOUND OUT THE STENT PREMATURE RELEASED 0.5CM WHILE PASSING DUODENAL PAPILLA WHICH CAUSE THE DEVICE CANNOT ENTER BILE DUCT. USER RETRACTED THE DEVICE FROM PATIENT AND CHECKED THE DEVICE FOUND OUT THE STENT CANNOT BE RETRACTED BACK INTO DELIVERY SYSTEM. USER CHANGED ANOTHER SAME DEVICE 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 ¿PREMATURE STENT DEPLOYMENT WITH SAFETY LOCK IN PLACE¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8988825 ↗
• MalfunctionApr 26, 2019Fracture; Fracture

  USER ADVANCED THE DEVICE THROUGH WIRE GUIDE WHILE FOUND OUT THE DELIVERY SYSTEM DETACHED FROM OUTER SHEATH. USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8554231 ↗
• MalfunctionNov 15, 2018Break; Break

  AS REPORTED TO CUSTOMER RELATIONS: "WHEN THEY WERE GOING TO DEPLOY THE STENT, THEY HAD A LOT OF RESISTANCE AND THE OUTER SHEATH BY THE HANDLE BECAME SEPARATED FROM THE HANDLE. ABOUT 2-3 CM FROM THE TIP OF THE CATHETER, THERE IS A KINK ON THE CATHETER. THE STENT IS PARTIALLY DEPLOYED (ABOUT 1 CM OF IT). DEVICE WAS REMOVED, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073138 ↗
• MalfunctionMay 2, 2018Premature Activation; Premature Activation

  INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: 'PREMATURE STENT DEPLOYMENT WITH THE SAFETY LOCK IN PLACE.' USER PLAN TO IMPLANT 2 STENT IN BOTH SIDE OF HEPATIC DUCT. ONE STENT WAS ADVANCED TO RIGHT HEPATIC DUCT SUCCESSFULLY, ANOTHER STENT WAS ADVANCED INTO ENDOSCOPY CHANNEL BUT WITH PART DEPLOYED WHILE EMERGED FROM ENDOSCOPY IN PATIENT. RED LOCK WAS IN PLACE AND SECURED AT THE MOMENT. USER DECIDED DEPLOYED THE ONE IN RIGHT HEPATIC DUCT WHICH TURNS OUT SUCCESSFULLY. AND THEN WITHDRAW THE PART DEPLOYED STENT ALONG WITH ENDOSCOPY FROM PATIENT. USER RELEASE THE STENT IN ENDOSCOPY CHANNEL AFTER WITHDRAW. USER WITHDRAW THE DEVICE FROM ENDOSCOPY AT LAST.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7479575 ↗
• MalfunctionDec 18, 2017Delivery System Failure; Delivery System Failure

  PER REP - "DEVICE WAS PLACED OVER GUIDE WIRE INTO LEFT INTRAHEPATIC DUCT. DEVICE WAS FLUSHED IN BOTH PORTS PRIOR TO INSERTION. UPON DEPLOYMENT, RESISTANCE WAS FELT AND THE PHYSICIAN RELAXED THE ELEVATOR ON THE SCOPE. ASSISTANT ATTEMPTED TO DEPLOY STENT WITH RESISTANCE AND THE CATHETER SEPARATED FROM THE LUER LOCK HANDLE RENDERING THE DEVICE USELESS. DEVICE HAD NOT DEPLOYED AND THE CATHETER WAS REMOVED LEAVING GUIDE WIRE IN PLACE AND A REPLACEMENT LIKE DEVICE WAS USED TO COMPLETE PROCEDURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7126845 ↗
• MalfunctionDec 14, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: THE SHEATH OF THE ZILVER STENT DISCONNECTED FROM THE HANDLE. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7116434 ↗
• MalfunctionMar 14, 2017Break; Break

  DURING THE STENT PLACEMENT PROCEDURE, THE CATHETER OF THE STENT BROKE AWAY FROM THE HANDLE AND DEPLOYMENT WAS UNABLE TO BE SUCCESSFUL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6402749 ↗
• MalfunctionFeb 7, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING ERCP, THE USER ADVANCED TWO STENTS ALONG WIRE GUIDE UNDER ENDOSCOPE THROUGH LEFT AND RIGHT HEPATIC DUCT. A -REPRESENT SENT THROUGH LEFT HEPATIC DUCT. B- -REPRESENT SENT THROUGH RIGHT HEPATIC DUCT. THE USER ADVANCED B INTO DESIRED POSITION SUCCESSFULLY AND TRIED TO DEPLOY TWO STENTS AT THE SAME TIME. THEN THEY FOUND THAT THE B STENT COULD NOT DEPLOY BECAUSE THE HANDLE PORTION WAS DETACHED. WITHDRAW THE STENT IMMEDIATELY. AFTER WITHDRAWING, ABOUT 55 CM DISTAL FROM THE END OF HANDLE OF OUTER SHEATH WAS PEELING. THE PEELED PORTION SHEATH WAS OPERATED OUTSIDE, SO NO SECTION WAS LEFT INSIDE PATIENT BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6307215 ↗
• InjuryFeb 2, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE CATHETER BROKE / SNAPPED IN HALF. THE ENTIRE CATHETER WAS PULLED OUT. A DIFFERENT STENT WAS USED AND PLACED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 06-JAN-2017 AS FOLLOWS: WILL THE COMPLAINT DEVICE STILL BE RETURNED FOR INVESTIGATION? YES SENT INFORMATION. AT WHAT POINT OF THE PROCEDURE THE CATHETER BROKE? WAS IT DURING DEPLOYMENT? STENT DEPLOYMENT. HOW DID THEY PULL THE DEVICE OUT FROM THE PATIENT? DID THEY USE FORCEPS OR ANY TOOLS TO RETRIEVE THE DEVICE? DEVICE STAYED IN PATIENT. ON RETRACTION OF STENT CATHETER, STENT DEPLOYED IN CBD. WHERE WAS THE POINT OF BREAKAGE??? WAS THE CATHETER PULLED FROM THE HANDLE MAYBE? I HAVE NO CLUE WHY THE CATHETER WAS PULLED FROM WHAT HANDLE? CAN THEY CONFIRM THAT THEY REFER TO THE OUTER CATHETER NOT THE INNER CATHETER? NO THAT SHOULD BE DETERMINED BY INVESTIGATING REPORT. BASED ON THE ADDITIONAL INFORMATION THE STENT WAS DEPLOYED IN THE CBD. ADDITIONAL INFORMATION CONFIRMED THIS WAS UNINTENTIONAL DEPLOYMENT. NO ADVERSE EFFECTS TO THE PATIENT ARE REPORTED. HOWEVER EVENT MEETS FDA 'MALFUNCTION' REPORTING CRITERIA. THE RISK IS NOT REMOTE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6295875 ↗
• MalfunctionJun 20, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING THE ERCP BOTH SIDE OF HEPATIC DUCT METAL ZILBS STENT PLACEMENT, THE FIRST STENT WAS PLACED WELL AND ADVANCE THE SECOND STENT THROUGH THE ENDOSCOPE. THE CONNECTION BETWEEN THE TIP AND OUTER SHEATH WAS PARTLY SEPARATED. THE RED SAFETY LOCK HAD NOT BEEN OPENED. THE USER WITHDREW THE STENT AND REPLACED WITH A NEW DEVICE TO FINISH THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5735425 ↗