Zilver 518 G31439Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002314396), received between Jul 18, 2019 and Mar 19, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

• MalfunctionMar 19, 2025Off-Label Use; Off-Label Use

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 8 JUL 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643310 ↗
• MalfunctionMar 20, 2024Off-Label Use; Off-Label Use

  THE DOCTOR WAS DEPLOYING THE STENT IN THE INTERNAL ILIAC. HE REMOVED THE SAFETY TAB AND STARTING TO PULL BACK ON THE DEPLOYMENT SYSTEM. THEY HEARD A SNAP BUT KEPT RETRACTING THE DEPLOYMENT SHEATH. AFTER THEY DEPLOYED THE STENT, THEY REALIZED THE SHEATH NEVER RETRACTED AND THE STENT WAS STILL INCAPSULATED IN THAT SHEATH RATHER THAN THE VESSEL. THEY PULLED OUT THE STENT DEPLOYMENT SYSTEM AND EVERYTHING CAME OUT OKAY. THE STENT SHOULD STILL BE IN THE SHEATH WHEN Y¿ALL REVIEW THE PARTS. PATIENT OUTCOME: THEY PULLED OUT THE STENT DEPLOYMENT SYSTEM AND EVERYTHING CAME OUT OKAY. NO PATIENT IMPACT REPORTED SG 23FEB2024. PATIENT/EVENT INFO - NOTES: THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA EMAIL ON 22FEB2024. SG 23FEB2024 1. WILL THE FACILITY BE REPORTING THIS TO A GOVERNMENT AGENCY (FDA, COMPETENT AUTHORITY, ETC.) NO 2. USAGE OF PRODUCT (PLEASE SELECT ONLY ONE BELOW): A. INITIAL USE OF DEVICE- INITIAL USE IS CORRECT. 3. WAS PRODUCT REPROCESSED FOR REUSE PRIOR TO OCCURRENCE? NO. 4. DID THE PRODUCT REGARDING THIS COMPLAINT COME IN CONTACT WITH THE PATIENT? A. CAN YOU PROVIDE ANY PATIENT INFORMATION (AGE, WEIGHT, GENDER, PRE-EXISTING CONDITIONS)? UNKNOWN. B. WHAT TYPE OF PROCEDURE WAS B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18939860 ↗
• MalfunctionSep 2, 2022Activation, Positioning or Separation Problem; Activation Problem; Activation, Positioning or Separation Problem; Activation Problem

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A MALE PATIENT OF UNSPECIFIED AGE UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE ZILVER 518 BILIARY SELF-EXPANDING STENT, G31439, WAS USED. THE STENT AND CATHETER WAS FLUSHED AND ONCE THE PRODUCT WAS OVER THE WIRE, INTRODUCED INTO PATIENT AND READY TO DEPLOY, THEY [THE END USER] CLAIM THE STENT WOULD NOT OPEN. THEY [THE END USER] REMOVED THE PRODUCT AT THIS TIME. REQUESTED 11AUG2022. TH 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO IF YES, PLEASE DESCRIBE. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? IF YES, PLEASE DESCRIBE. 4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. 5. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. 6. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15345048 ↗
• MalfunctionJul 18, 2019Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  UPON TRYING TO USE STENT, SHEATH DISCONNECTED FROM THE DEPLOYMENT HANDLE. THE DEVICE WAS ABLE TO BE DEPLOYED, BUT THE SHEATH WAS HELD MANUALLY. THE DEVICE WAS PLACED IN PROXIMAL POPLITEAL INSTEAD OF DISTAL POPLITEAL/ANTERIOR TIBIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8802835 ↗