Zilver 518 G43777Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002437774), received between Jun 7, 2018 and May 15, 2026 — classified as 4 malfunctions.

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

• MalfunctionMay 15, 2026Off-Label Use

  A PATIENT OF UNDISCLOSED AGE AND GENDER UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE ZILVER 518 VASCULAR SELF-EXPANDING STENT, G43777, WAS USED. THE HUB OF THE DETACHMENT PART ON THE CATHETER CAME APART FROM THE SHEATH AND THE CATHETER WOULD NOT DEPLOY/DETACH. THEY PULLED THE RED SAFETY TAB, HAD SOME RESISTANCE WHEN TRYING TO PIN PULL. THEY DID ADMIT IT MAY HAVE BEEN USER ERROR- WAS UNNECESSARILY FORCEFUL WITH THE BLACK HUB. THEY WERE ABLE TO SAFELY REMOVE THE DEFECTIVE ZILBER AND PLACE A NEW ZILVER SUCCESSFULLY. NO ISSUES WITH PATIENT AND NO ADDITIONAL MEASURES WERE NECESSARY. THE DEVICE WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS SEEN. THE TARGET LOCATION FOR THE STENT WAS THE TRANSVERSE VENOUS SINUS (OFF IFU) TO TREAT THE DISEASE PATHOLOGY OF IDIOPATHIC INTRACRANIAL HYPERTENSION (IIH). PRE-DILATION WAS NOT PERFORMED AHEAD OF STENT PLACEMENT. AN ASAHI WIRE GUIDE WAS USED DURING THE PROCEDURE. THE PATIENT HAD NO STENTS PREVIOUSLY PLACED DURING PRIOR PROCEDURES BUT DID EXHIBIT DIFFICULT, TORTUOUS ANATOMY. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191574 ↗
• MalfunctionMar 14, 2023Off-Label Use; Off-Label Use

  AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "UNABLE TO UN-SHEATH THE DEVICE, THIS OCCURRED WHILE THE DEVICE WAS INSIDE THE PATIENT AS THE PHYSICIAN WAS ATTEMPTING TO DEPLOY IT. A NEW G43777-ZIV5-18-125-7-60 WAS OPENED AND USED TO COMPLETE THE INTENDED PROCEDURE SUCCESSFULLY". DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? - NO. · IF YES, PLEASE DESCRIBE. - N/A. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? - NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? - NO. · IF YES, PLEASE DESCRIBE. - N/A. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? - NO. · IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. - N/A. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? - NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? - NO. · PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. - N/A. 3.32 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO. 3.33 AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? UNPACKING OR PREPARATION OF THE DEVICE, INSER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535692 ↗
• MalfunctionMay 10, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE COMPLAINT ZIV5-18-125-7-60 WAS USED FOR EVT. THE ACCESS WAS OBTAINED FROM THE FEMORAL ARTERY. WHEN THE PHYSICIAN DELIVERED THE DEVICE WITH A CONTRALATERAL APPROACH, THE RADIOPAQUE MARKER OF THE PROXIMAL TIP ON THE SHEATH BECAME OUT OF POSITION WHILE THE RADIOPAQUE MARKERS ON THE DISTAL TIP AND A STENT DID NOT MOVE. THE PHYSICIAN CONTINUED TO USE THE COMPLAINT DEVICE AND ENDED THE PROCEDURE. THERE WERE NO OTHER PROBLEMS, AND THE PATIENT REPORTEDLY EXPERIENCED NO ADVERSE EFFECTS ON THIS INCIDENT. UPDATED ON APRIL 2, 2019 BY (B)(6): THE PROXIMAL RADIOPAQUE MARKER ON THE INNER CATHETER BECAME OUT OF POSITION. THE PROXIMAL RADIOPAQUE MARKER ON THE INNER CATHETER BECAME OUT OF POSITION WHILE THE DISTAL RADIOPAQUE MARKER OF THE SHEATH AND THE RADIOPAQUE MARKER ON THE STENT DID NOT MOVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8598537 ↗
• MalfunctionJun 7, 2018Off-Label Use; Activation, Positioning or Separation Problem; Off-Label Use; Activation, Positioning or Separation Problem

  THIS DEVICE BECAME STUCK INSIDE OF A NAVIEN GUIDE CATH. THE INNER DIAMETER OF THE NAVIEN .IS 072 IN / 1.8 MM. THE COOK DEVICE HAS AN OUTER DIAMETER OF .066 IN / 167 MM. THE STENT WENT IN BUT WOULD NOT COME OUT. IN ATTEMPTING TO REMOVE THE STENT FROM THE GUIDE CATH, IT STRETCHED THE STENT DELIVERY SYSTEM. THE STENT WAS NOT DEPLOYED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER STENT. THE STENT WAS DEPLOYED BENCH TOP AFTER THE PROCEDURE AND THE STENT LOOKED DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7576997 ↗