Zilver G25730Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002257303), received between Apr 12, 2016 and Jun 20, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (2 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 18, 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.

• MalfunctionJun 20, 2025Unintended Ejection; Malposition of Device; Unintended Ejection; Malposition of Device

  DURING AN UNKNOWN BILE DUCT PROCEDURE, THE PHYSICIAN USED A COOK ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM. IT WAS REPORTED THAT THE USER DETECTED THE INNER CORE DETACHMENT, THEN IMMEDIATELY CHANGED TO A NEW DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302051 ↗
• MalfunctionOct 21, 2021Unintended Ejection; Malposition of Device; Unintended Ejection; Malposition of Device

  DURING A METAL STENT PLACEMENT PROCEDURE, THE PHYSICIAN USED A COOK ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM. THE STENT SLIPPED OUT OF THE CATHETER AND COULD NOT BE DEPLOYED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12678084 ↗
• InjurySep 15, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM. THE USER DEPLOYED THE STENT WITHOUT AN ISSUE. THE TIP OF THE INNER SHEATH DETACHED AND REMAINED IN THE PATIENT. ONE PART OF THE BROKEN TIP IS IN THE HILAR BILE DUCT AND THE OTHER PART IS IN THE PATIENT'S STOMACH. ADDITIONAL INFORMATION WAS RECEIVED ON 14-SEPTEMBER-2020 WHICH STATES THAT THE USER REMOVED THE REMAINING PART OF DEVICE BY FORCEPS UNDER AN ADDITIONAL ENDOSCOPIC PROCEDURE. A SECTION OF THE DEVICE DETACHED INITIALLY, BUT ULTIMATELY DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE DETACHED INNER SHEATH WAS RETRIEVED 4 DAYS AFTER THE PROCEDURE DUE TO THIS OCCURRENCE DURING ANOTHER ENDOSCOPIC PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10538002 ↗
• MalfunctionApr 12, 2016Separation Failure; Separation Failure

  DURING AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM. PER THE INFORMATION PROVIDED ON THE COOK COMPLAINT REPORTING FORM: ON THE PROCEDURE, THE STENT CANNOT TO DEPLOY AND RETURN [UNABLE TO DEPLOY]. PER CLARIFICATION RECEIVED ON 03/09/2016: THE STENT CAN DEPLOY ABOVE 3 MM [STENT WILL ONLY DEPLOY 3MM] AND METAL STENT WILL ADHERE THE INTRODUCER CANNOT PUSH TO DEPLOY [STENT CANNOT DEPLOY]. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION ON 03/18/2016, IT WAS NOTED THAT THE STENT WAS DEPLOYED MORE THAN 1 CM. CLARIFICATION WAS REQUESTED. ON 03/22/2016, THE FOLLOWING WAS PROVIDED FROM THE COOK SALES REPRESENTATIVE: THIS DEVICE IS SINGLE USE DEVICE, SO I CANNOT CHECK WHETHER IT CAN DEPLOY [BE DEPLOYED] BEFORE USING. IN THIS CASE, THE DEVICE ENTERED TO THE BODY OF PATIENT AND DEPLOYED MORE THAN 1 CM. HOWEVER, IT COULD NOT DEPLOY COMPLETELY. SO THE DOCTOR TOOK IT OUT FROM THE PATIENT'S BODY AND RETURNED IT TO US. DUE TO THE HYGIENE REASON, THE NURSE HAD CLEANED UP THE DEVICE BEFORE RETURNING. THEREFORE, IT CANNOT SEE ANY BODILY FLUID ON THE DEVICE [BODILY FLUID CANNOT BE SEEN ON THE DEVICE] BUT IT COULD BE CONFIRMED THAT THIS DEVICE WAS USED INSIDE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5570920 ↗