Zilver 518 G43788Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002437880), received between Oct 27, 2023 and Jan 7, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (5 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.

• MalfunctionJan 7, 2026Off-Label Use

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 18-FEB-26.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986869 ↗
• MalfunctionDec 1, 2025Off-Label Use; Off-Label Use

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 22-JAN-2026. ADDITIONAL QUESTIONS ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? -NO. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? UNPACKING OR PREPARATION OF THE DEVICE, INSERTION, STENT PLACEMENT, REMOVING THE INTRODUCER. -ATTEMPTED DEPLOYMENT DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? -UNKR NAME, 6 FR, 90 CM. WHAT WAS THE TARGET LOCATION FOR THE STENT? -BRAIN. WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? -YES. WAS THE DEVICE USED PERCUTANEOUSLY? -YES. WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORT BEFORE THE PROCEDURE, AS PER IFU? -YES. WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? -NO. WAS POST-DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? -N/A. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHILIC)? -UNKR NAME, .014, NOT HYDROPHILIC. DID THE PATIENT EXHIBIT DIFFICULT OR ALTERED ANATOMY (IF ALTERED PLEASE SPECIFY HOW IT IS ALTERED)? N/A, TORTUOUS, CALCIFIED, ALTERED -IT WAS NATURALLY TORTUOUS (NORMAL FOR BRAIN). THE DELIVERY SYSTEM WENT THROUGH THE TORTUOSITY FAIRLY EASILY. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23689548 ↗
• MalfunctionJan 11, 2024Off-Label Use; Off-Label Use

  PER REP - 14DEC2023 - THEY WERE BACK LOADING THE WIRE THROUGH THE DELIVERY CATHETER. WHEN THE WIRE GOT TO THE METAL CANNULA, THERE WAS A LOT OF RESISTANCE. TO PULL THE WIRE THROUGH TOOK A TON OF FORCE BUT THEY WERE ABLE TO DO IT BECAUSE IT WAS OUTSIDE THE PATIENT. IT WAS AS IF THE CANNULA WAS NOT (B)(4) COMPATIBLE. THE DEVICE WAS SUCCESSFULLY DEPLOYED AND THE SYSTEM WAS REMOVED FROM THE PATIENT. THERE WERE NO PROBLEMS WITH THE ACTUAL PLACEMENT OF THE STENT. EVERYTHING WENT PERFECTLY. ZIV5/ZIV6/ZFV6 3.32 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO -NO 3.33 AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? UNPACKING OR PREPARATION OF THE DEVICE, INSERTION, STENT PLACEMENT, REMOVING THE INTRODUCER. -PREPARATION 3.34 DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? -WHEN THE PROBLEM OCCURRED, THE SHEATH WAS NOT INVOLVED. 3.35 WHAT WAS THE TARGET LOCATION FOR THE STENT? -VENOUS SINUS 3.36 WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? N/A, YES, NO -YES 3.37 WAS THE DEVICE USED PERCUTANEOUSLY? N/A, YES, NO -YES 3.38 WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORT BEFORE THE PROCEDURE, AS PER IFU? N/A, YES, NO -YES 3.39 WAS PRE-DILATION PERFORMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491561 ↗
• MalfunctionNov 17, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS WAS A CASE OF CONTRALATERAL APPROACH TO AN EXTERNAL ILIAC ARTERY. ZIV5-18-125-9-60 WAS ATTEMPTED TO BE DEPLOYED, BUT THE OUTER SHEATH CAME OFF THE HUB SO IT WAS TAKEN OUT OF THE PATIENT. ((B)(4)). THE USER CHANGED THE WIRE GUIDE FROM 0.014 INCH TO 0.018 INCH AND TRIED DEPLOYING AGAIN WITH ZIV5-18-125-9-80, BUT THE OUTER SHEATH CAME OFF AGAIN. ((B)(4)). THE PROCEDURE WAS COMPLETED BY FORCIBLY PULLING THE OUTER SHEATH OF ZIV5-18-125-9-80 AND DEPLOYING THE STENT - USER ERROR. ((B)(4)). <PHYSICIAN'S COMMENT> THE PATIENT'S ANATOMY WAS HIGHLY TORTUOUS, WHICH MAY HAVE BEEN A FACTOR. 3-1 WAS THE DEVICE USED PERCUTANEOUSLY? YES. 3-2 WHICH ARTERY WAS THE STENT TO BE PLACED IN? EIA (EXTERNAL ILIAC ARTERY). 3-3 WAS THE APPROACH IPSILATERAL OR CONTRALATERAL? (CONTRALATERAL). 3-4 IF CONTRALATERAL, WAS THE BIFURCATION ANGLE TIGHT? YES. 3-5 WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? FA (FEMORAL ARTERY). 3-6 DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? MEDIKIT/PARENT PLUS 60 6FR 75CM. 3-7 WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORT BEFORE THE PROCEDURE, AS PER IFU? YES. 3-8 DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? NIPRO/CHEVALIER FLOOPY 0.014IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158978 ↗
• MalfunctionOct 31, 2023Off-Label Use; Off-Label Use

  THE STENT WAS DEPLOYED, BUT THE STENT NEVER CAME OFF OF THE DEPLOYMENT SYSTEM. THE STENT WAS ABLE TO BE SUCCESSFULLY REMOVED FROM THE PATIENT. THE FOLLOWING INFORMATION HAS BEEN REQUESTED VIA EMAIL ON 11AUG2023 / 19SEP2023 25SEP2023. SG 25SEP2023. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? PROVIDED IN COMPLAINT EMAIL. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? STENT PLACEMENT. WAS POST-DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? N/A. WAS THE STENT DEPLOYED SMOOTHLY / WITHOUT RESISTANCE? NO, STENT NEVER CAME OFF OF THE DEPLOYMENT SYSTEM. WHAT ARTERY WAS THE STENT PLACED IN? N/A. WAS THE STENT FULLY DEPLOYED FROM THE DELIVERY SYSTEM PRIOR TO REMOVAL OF THE DELIVERY SYSTEM? NO, STENT NEVER CAME OFF OF THE DEPLOYMENT SYSTEM. THE FOLLOWING INFORMATION HAS BEEN REQUESTED VIA EMAIL ON 11AUG2023 / 19SEP2023. SG 19SEP2023. 1. CONTACT AT FACILITY AND CONTACT INFO: 2. WILL THE FACILITY BE REPORTING THIS TO A GOVERNMENT AGENCY (FDA, COMPETENT AUTHORITY, ETC.). 3. WILL THE PRODUCT BE RETURNED? A. IF YES A RETURN LABEL WILL BE PROVIDED. 4. USAGE OF PRODUCT (PLEASE SELECT ONLY ONE BELOW): A. INITIAL USE OF DEVICE. B. REUSE OF DEVICE. C. UNKNOWN. 5. WAS PRODUCT REPROCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18036903 ↗
• MalfunctionOct 27, 2023Off-Label Use; Off-Label Use

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 06-JUN-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021759 ↗