Zilver 635 G36013Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002360133), received between Apr 5, 2017 and Sep 8, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  WHEN THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE REPORTED STENT (WHEN PULLING THE HANDLE TOWARD THE HUB), THE SHEATH GOT SEPARATED. THEREFORE, HE PULLED ONLY THE SHEATH PART, AND THE STENT PLACEMENT MANAGED TO BE COMPLETED. NO ADVERSE EVENTS TO THE PATIENT WERE REPORTED. PHYSICIAN'S COMMENT: I WOULD LIKE THE MANUFACTURER TO INVESTIGATE THE CAUSE. PREFIX ZIB6: WAS THE DEVICE USED PERCUTANEOUSLY? YES. WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? RIGHT BILE DUCT DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? N/A. WHAT WAS THE TARGET LOCATION FOR THE STENT? 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)? UNKNOWN. WAS THE PATIENT'S ANATOMY TORTUOUS OR CALCIFIED? NO) WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE OR DELIVERY SYSTEM TO THE TARGET LOCATION? UNKNOWN. HOW DID THE PHYSICIAN DEAL WITH THIS RESISTANCE? WAS THE TARGET LOCATION CALCIFIED? UNKNOWN. DID THE TIP OF THE DELIVERY SYSTEM CROSS THE TARGET LOCATION? YES. ARE IMAGES OF THE DEVICE OF PROCEDURE AVAILABLE? NO. DID THE USER PULL THE HANDLE TOWARD THE HUB DURING DEPLOYMENT AND DEL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12437536 ↗
• MalfunctionOct 22, 2020Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS

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

  MAUDE report 10721745 ↗
• MalfunctionJul 10, 2018Material Separation; Material Separation

  INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿FLEXOR BREAKING DURING DEPLOYMENT (INCL. FLEXOR/HANDLE SEPARATION)¿. PERCUTANEOUS METALLIC STENT PLACEMENT IN BILE DUCT BY APPROACH FROM ABDOMINAL REGION WAS PERFORMED. AFTER THE DELIVERY SYSTEM OF THE COMPLAINT ZIB6-40-10.0-80 REACHED THE TARGET LESION, DEPLOYMENT OF THE STENT WAS BEGUN. HOWEVER, DURING THE WITHDRAWAL OF THE HANDLE, THE OUTER SHEATH GOT SEPARATED FROM THE HANDLE. THE SYSTEM WAS RETRIEVED OUT OF THE BODY, ANOTHER DEVICE WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7672926 ↗
• MalfunctionApr 5, 2017Break; Material Separation; Break; Material Separation

  THE OUTER SHEATH GOT SEPARATED FROM THE HANDLE DURING USE, SO THE STENT COULD NOT BE PLACED. THEN, ANOTHER MANUFACTURER'S DEVICE WAS USED INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6460347 ↗