Zilver 635 G23815Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002238159), received between Apr 16, 2019 and Mar 24, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• MalfunctionMar 24, 2026Improper or Incorrect Procedure or Method

  THE ZILBS-635-10-10 WAS ADVANCED VIA THE PAPILLA TOWARD THE HILAR BILE DUCT; HOWEVER, IT WAS UNABLE TO CROSS THE STRICTURE. A NON-COOK STENT WAS PLACED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION PROVIDED BY THE SALES REP ON 26FEB2026: WAS THERE ANY EVIDENCE THAT THE SHEATH/CATHETER BEING KINKED WHEN THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT? NO. WHAT ENDOSCOPE CHANNEL SIZE WAS USED? 3.7MM (OLYMPUS, JF-260V). DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER)? ALREADY PROVIDED IN OTHER NON-COOK PRODUCTS (FIELDER 025, 025INCH GW). DID THE PATIENT EXHIBIT DIFFICULT ANATOMY? NO. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM (E.G., KINKS) PRIOR TO RETURN? NO. WAS THE DELIVERY SYSTEM TRACKED AROUND A TIGHT ANGLE IN THE PATIENT ANATOMY OR AROUND A TIGHT ANGLE IN AN ENDOSCOPE? NONE OTHER THAN THE REPORTED STRICTURE. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? NO RESISTANCE WAS ENCOUNTERED UNTIL THE REPORTED STRICTURE. IF RESISTANCE WAS FELT HOW DID THE PHYSICIAN DEAL WITH THE RESISTANCE ENCOUNTERED? NA. WHAT WAS THE POSITION OF THE ELEVATOR DURING ADVANCEMENT? IT WAS SET TO OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673192 ↗
• MalfunctionJun 20, 2024Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 12-SEP-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19572980 ↗
• MalfunctionJun 22, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE USER PULLED THE SHEATH TO DEPLOY THE STENT AT THE STENOSED SITE IN THE BILE DUCT, BUT HE CONFIRMED FLUOROSCOPICALLY THE STENT WAS NOT DEPLOYED. HE REPLACED IT WITH ANOTHER ZILVER 635 BILIARY SELF EXPANDING METAL STENT AND PLACED THE STENT WITHOUT PROBLEM TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE 2ND ZILVER 635 BILIARY SELF EXPANDING METAL STENT HAD NO PROBLEM AT ALL, SO PLEASE INVESTIGATE THE DEVICE IN QUESTION TO FIND THE CAUSE. "(IF ANY DAMAGES WERE CONFIRMED PRIOR TO USE) WAS THE PACKAGE DAMAGED?" NO. "WAS A SPHINCTEROTOMY OR BALLOON DILATION PERFORMED PRIOR TO USE OF THE STENT DEVICE?" EST WAS PERFORMED. "WAS POST-DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT?" NO. "WHAT BRAND OF ENDOSCOPE WAS USED WITH THE DEVICE?" OLYMPUS' TJF-260V. "WHAT WAS THE TARGET LOCATION FOR THE COMPLAINT DEVICE?" HILAR BILE DUCT TO COMMON BILE DUCT. "WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE, AS PER IFU?" YES. "DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)?" BOSTON SCIENTIFIC'S ENDOSELECTOR 0.025 INCH. "WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE OR DELIVERY SYSTEM TO T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14775559 ↗
• InjurySep 21, 2020Off-Label Use; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Off-Label Use; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO THE INVESTIGATION BEING COMPLETED 26-MAR-2021.

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

  MAUDE report 10564267 ↗
• MalfunctionJul 18, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  UPDATED ON 12/JUNE /2019. OLYMPUS'S JF-260V WAS INSERTED IN THE BODY AND BLIARY CANNULATION WAS PERFORMED. THEN, OLYMPUS'S VISIGLIDE2 WIRE GUIDE INSERTED IN THE BILE DUCT. ZILBS-635-10-10 /LOT: C1536124 WAS INSERTED OVER THE WIRE GUIDE. THE USER ATTEMPTED TO PASS THE DELIVERY SYSTEM THROUGH THE BILIARY STENOSIS BUT THE DELIVERY SYSTEM DID NOT PASS THROUGH THE STENOSIS, SO HE REMOVED THE DELIVERY SYSTEM FROM THE BODY. HE CHECKED THE DELIVERY SYSTEM AND HE FOUND A FRAY ON THE TIP OF THE DELIVERY SYSTEM. HE DEPLOYED ONE THIRD OF THE STENT OUTSIDE THE BODY AND IT SEEMED THAT THE STENT HAD NO PROBLEM TO DEPLOY. HE USED ANOTHER DEVICE (ZEON MEDICAL'S ZEOSTENT-V DIA.10MM, 8CM LONG) INSTEAD AND COMPLETED THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. LAB EVALUATION CONDUCTED ON THE 20 JUN 2019 CONFIRMED THE DELIVERY SYSTEM WAS KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8802397 ↗
• MalfunctionApr 16, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE DELIVERY SYSTEM OF THE COMPLAINT DEVICE WAS ADVANCED OVER OLYMPUS'S WIRE GUIDE (VISIGLIDE 0.025INCH) WHICH WAS PREVIOUSLY PLACED IN THE B3 (BILE DUCT #3) VIA THE PAPILLA. WHEN THE USER STARTED TO DEPLOY THE STENT IN THE B3, THE SHEATH BROKE WHICH MADE IT IMPOSSIBLE TO DEPLOY THE STENT. THE ENTIRE DELIVERY SYSTEM COULD BE REMOVED FROM THE PATIENT AND THE DEVICE WAS REPLACED WITH ZILBS-635-10-12 TO COMPLETE THE PROCEDURE.NO PORTION OF HE DEVICE REMAINED INSIDE THE PATIENT AND THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8518324 ↗