Zilver 635 G23816Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002238166), received between Oct 2, 2020 and Jul 17, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionJul 17, 2023Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 25-OCT-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333000 ↗
• MalfunctionApr 3, 2023Break; Material Integrity Problem; Break; Material Integrity Problem

  THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE COMPLETION OF THE INVESTIGATION ON 24-MAY-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662758 ↗
• MalfunctionApr 3, 2023Break; Material Integrity Problem; Break; Material Integrity Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 25-MAY-23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662756 ↗
• MalfunctionMay 11, 2021Break; Activation, Positioning or Separation Problem; Activation Problem; Break; Activation, Positioning or Separation Problem; Activation Problem

  SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT ADDITIONAL INFORMATION AND RECEIPT OF THE COMPLAINT DEVICE FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED 17-MAY-2021 AS FOLLOWS: THE REP'S REPLY ON ADDITIONAL INFORMATION REQUEST WAS RECEIVED FROM THE REP ON 17/5/21 JIL01: 1. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO. 2. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? DURING STENT PLACEMENT . 3. WAS A SPHINCTEROTOMY PERFORMED PRIOR TO USE OF THE STENT DEVICE? YES. 4. WAS BALLOON DILATION PERFORMED PRIOR TO USE OF THE STENT DEVICE? NO. 5. WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? UNKNOWN. 6. WHAT BRAND OF ENDOSCOPE WAS USED WITH THE DEVICE? OLYMPUS. 7. WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? YES. 8. WHAT WAS THE POSITION OF THE ELEVATOR DURING DEPLOYMENT? , OPEN. 9. WAS THE DELIVERY SYSTEM TRACKED AROUND A TIGHT ANGLE IN THE PATIENT ANATOMY OR AROUND A TIGHT ANGLE IN AN ENDOSCOPE? , YES. 10. WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE, AS PER IFU? YES, 11. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHYLLIC)? UNKNOWN. 12. WHAT WAS THE TARGET LOCATION FOR THE STENT? HILAR. 13. WAS THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11804439 ↗
• MalfunctionOct 2, 2020Off-Label Use; Material Deformation; Off-Label Use; Material Deformation

  THE PATIENT PREVIOUSLY HAD CHOLEDOCHOJEJUNOSTOMY UNDERWENT METALIC BILIARY STENT PLACEMENT. THE USER ADVANCED THE DELIVERY SYSTEM TO THE HEPATIC PORTAL REGION USING OLYMPUS' SINGLE BALLOON SHORT TIE SCOPE (SIF-290), AND ATTEMPTED TO DEPLOY THE STENT. HOWEVER, THE HANDLE WAS TOO TIGHT AND WOULD NOT MOVE/PULL AND THE DISTAL SIDE OF THE SHEATH GOT DAMAGED DURING ATTEMPT OF DEPLOYMENT. HE REPLACED IT WITH ANOTHER ZILVER 635 BILIARY SELF EXPANDING METAL STENT(LOT UNKNOWN) AND PLACED THE STENT AT THE TARGET SITE SUCCESSFULLY. THE HANDLE OF THIS REPLACEMENT WAS FAIRLY TIGHT AS WELL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. PREFIX ZILBS: WAS A SPHINCTEROTOMY OR BALLOON DILATION PERFORMED PRIOR TO USE OF THE STENT DEVICE? - NO. WAS POST-DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? - NO. WHAT BRAND OF ENDOSCOPE WAS USED WITH THE DEVICE? OLYMPUS' SIF-290. WHAT WAS THE TARGET LOCATION FOR THE COMPLAINT DEVICE? HEPATIC PORTAL. REGION WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE, AS PER IFU? YES. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? ASKU. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE OR DELI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10618561 ↗