Zilver 518Recalls & reported problems across all models

We found 20 models of Zilver 518 by Cook Ireland Ltd in the FDA's device registry (GUDID). Together they are named in 83 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2016 and May 15, 2026 — classified as 2 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (50 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Zilver 518 problems

Zilver 518 models

20 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Zilver 518 G43778

  STENT, ILIAC
  14 reports
• Zilver 518 G43783

  STENT, ILIAC
  9 reports
• Zilver 518 G43773

  STENT, ILIAC
  7 reports
• Zilver 518 G43788

  STENT, ILIAC
  6 reports
• Zilver 518 G43782

  STENT, ILIAC
  5 reports
• Zilver 518 G31439

  CATHETER, BILIARY, DIAGNOSTIC
  4 reports
• Zilver 518 G36048

  CATHETER, BILIARY, DIAGNOSTIC
  4 reports
• Zilver 518 G43777

  STENT, ILIAC
  4 reports
• Zilver 518 G43781

  STENT, ILIAC
  4 reports
• Zilver 518 G43787

  STENT, ILIAC
  4 reports
• Zilver 518 G31352

  CATHETER, BILIARY, DIAGNOSTIC
  3 reports
• Zilver 518 G43771

  STENT, ILIAC
  3 reports
• Zilver 518 G43791

  STENT, ILIAC
  3 reports
• Zilver 518 G43793

  STENT, ILIAC
  3 reports
• Zilver 518 G36047

  CATHETER, BILIARY, DIAGNOSTIC
  2 reports
• Zilver 518 G43772

  STENT, ILIAC
  2 reports
• Zilver 518 G43786

  STENT, ILIAC
  2 reports
• Zilver 518 G43792

  STENT, ILIAC
  2 reports
• Zilver 518 G31441

  CATHETER, BILIARY, DIAGNOSTIC
  1 report
• Zilver 518 G43780

  STENT, ILIAC
  1 report

Recent Zilver 518 adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionMay 7, 2026Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED THE STENT; HOWEVER, A PORTION OF IT WAS POSITIONED INCORRECTLY. THE DEVICE REPRESENTATIVE INDICATED THAT THERE WERE NO DEFECTS OR ISSUES WITH THE STENT ITSELF. THE PHYSICIAN PERFORMED A WIRE EXCHANGE PRIOR TO ADVANCING THE STENT; HOWEVER, THE GUIDEWIRE INADVERTENTLY TRACKED INTO AN UNINTENDED PATHWAY. AS A RESULT, WHEN THE STENT WAS DEPLOYED, IT WAS NOT POSITIONED AS EXPECTED. THE STENT ITSELF FUNCTIONED AS INTENDED. PATIENT WAS REPORTED FINE. CAN YOU CLARIFY WHAT EXACTLY IS MEANT IN THE DESCRIPTION OF EVENT: ¿¿A PORTION OF THE STENT WAS POSITIONED INCORRECTLY.¿ DOES THIS MEAN THAT A USE ERROR MAY HAVE OCCURRED AND IF SO, WHAT PART OF THE IFU WOULD THIS REFER TO? THE PHYSICIAN PERFORMED A WIRE EXCHANGE PRIOR TO ADVANCING THE STENT; HOWEVER, THE GUIDEWIRE INADVERTENTLY TRACKED INTO AN UNINTENDED PATHWAY. AS A RESULT, WHEN THE STENT WAS DEPLOYED, IT WAS NOT POSITIONED AS EXPECTED. THE STENT ITSELF FUNCTIONED AS INTENDED. WHAT WAS THE TARGET LOCATION FOR THE STENT? THE INTENDED TARGET LOCATION FOR THE STENT IS UNKNOWN, AS THE DEVICE WAS USED OFF-LABEL. WHAT DISEASE PATHOLOGY WAS BEING TREATED? UNKNOWN, AS THE DEVICE WAS USED OFF-LABEL. WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115777 ↗
• MalfunctionMar 3, 2026Off-Label Use; Difficult to Advance

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN SFA STENTING PROCEDURE IN WHICH THE ZILVER 518 VASCULAR SELF-EXPANDING STENT, G43772, WAS USED. PHYSICIAN PERFORMED AN ATHERECTOMY WHICH WENT WELL AND REMOVED THE DEVICE USED FOR THE ATHERECTOMY. PHYSICIAN LOADED THE STENT AND WAS GOING UP AND OVER THE BIFURCATION. THE STENT GOT LOCKED ON THE WIRE AND WAS UNABLE TO ADVANCE OVER THE WIRE OR TO DEPLOY. THE DEVICES WERE REMOVED AND ANOTHER OF THE SAME ZILVER AND WIRE WAS USED TO COMPLETE THE PROCEDURE. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? - NO AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? - INSERTION/STENT PLACEMENT DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? - 6FR FLEXOR ANSEL SHEATH WHAT WAS THE TARGET LOCATION FOR THE STENT? - SFA, NOT INFORMED WHICH SIDE WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? - YES, NOTHING NOTED 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? - YES DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHILIC)? - NOT INFORMED-

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496461 ↗
• MalfunctionFeb 3, 2026Off-Label Use; Structural Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 11-MAR-26. RESPONSE TO THE BELOW QUESTIONS WAS RECEIVED ON 05-FEB-2026: DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? - 6 FR SHUTTLE CORK. WHAT WAS THE TARGET LOCATION FOR THE STENT? - RIGHT TRANSVERSE SINUS. WHAT WAS THE ACCESS SITE CHOSEN? - RT FEMORAL ARTERY. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHILIC)? - ARISTOLE 0.014. WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? - NO. WAS THE APPROACH IPSILATERAL OR CONTRALATERAL? - NO. WHAT INTERVENTION (IF ANY) WAS REQUIRED? - NONE. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? - YES , SAME DAY. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM PRIOR TO RETURN (E.G., KINK)? - NO. WAS THE STENT BEING PLACED THROUGH THE SIDE WALL OF A PREVIOUSLY PLACED STENT? - NO. DID ANY PART OF THE PRODUCT SNAG/GET CAUGHT ON THE STENT WHEN REMOVING THE DELIVERY SYSTEM? - NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247066 ↗
• 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 ↗
• MalfunctionNov 25, 2025Off-Label Use; Off-Label Use

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 15-JAN-26. THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA EMAIL ON 02DEC2025. 1. IS AN ACKNOWLEDGMENT LETTER (FORMAL NOTIFICATION OF THE COMPLAINT BEING RECEIVED) REQUIRED? NO. 2. IS ANY ACCOUNT ACTION NEEDED (CREDIT, NO CHARGE REPLACEMENT, NO ACTION, INVESTIGATION RESULTS, ETC.) NO. 3. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? NOT SURE. 4. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHILIC)? BOSTON V18. 5. WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? NO. 6. WAS THE APPROACH IPSILATERAL OR CONTRALATERAL? N/A, ISPILATERAL, CONTRALATERAL (IF CONTRALATERAL, WAS THE BIFURCATION ANGLE STEEP? N/A, YES, NO) CONTRA. UP INTO SINUS 7. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM PRIOR TO RETURN (E.G., KINK)? N/A, YES, NO (IF YES, PLEASE SPECIFY WHAT ADDITIONAL DEFECT(S) WERE OBSERVED AND WHERE ON THE DEVICE THIS WAS OBSERVED) NO. 8. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? YES. 9. DID THE TIP OF THE DELIVERY SYSTEM CROSS THE TARGET LOCATION? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643460 ↗
• MalfunctionMay 23, 2025Off-Label Use; Off-Label Use

  DEVICE WOULDN¿T TRACK OVER WIRE TO DESIRED LOCATION. THEN IT DID NOT FIT THROUGH A 071 ID BENCH TOP CATHETER. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077321 ↗
• MalfunctionMar 31, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 20-MAY-25.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729551 ↗
• MalfunctionMar 26, 2025Device Damaged Prior to Use; Manufacturing, Packaging or Shipping Problem; Device Damaged Prior to Use; Manufacturing, Packaging or Shipping Problem

  UPON WITHDRAWAL OF STENT DELIVERY SYSTEM FROM THE PACKAGING AND FLUSHING PROCESS, IT WAS NOTICED THAT THERE WAS A GAP AT THE DISTAL END OF THE SYSTEM BETWEEN THE OUTER SHEATH AND THE WHITE INNER CATHETER TIP. DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE IS OCCURRENCE. ((B)(6)). THIS ADDITIONAL COMPLAINT WAS OPENED TO CAPTURE THE STENT STRUT DAMAGE SEEN IN THE DEVICE EVALUATION. ENGINEERING INPUT CONFIRMED THIS DAMAGE WAS UNRELATED TO THE ORIGINAL COMPLAINT REPORTED. NO PATIENT INFORMATION PROVIDED AS DEVICE WAS NOT USED ON THE PATIENT. PRIOR TO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702065 ↗
• 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 ↗
• MalfunctionJan 23, 2025Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A 8 BY 80 ZILVER 518 STENT DID NOT DEPLOY CORRECTLY DURING AN OFF-LABEL SINUS STENT AS PER THE DR. IT WAS STATED NEURO STARTED TO DEPLOY THE STENT, SHE MET RESISTANCE AT THE STENOSIS AS THE ARMADILLO KEPT PUSHING UP MAKING IT DIFFICULT TO CONTINUE TO DEPLOY. THERE WAS A LOT OF TENSION. SHE STOPPED DEPLOYING TO SEE SITUATION. BUT AS THE STENT CONTINUED TO UNSHEATH, IT STARTED TO STRETCH OUT THE STENT BEFORE IT WAS FULLY DEPLOYED AT DISTAL END. NOT FULLY DEPLOYED CORRECTLY. IT WAS REPORTED THAT "THE PATIENT IS FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217721 ↗
• MalfunctionJun 27, 2024Off-Label Use; Off-Label Use

  DESCRIPTION OF EVENT: THE PROXIMAL END OF THE STENT WAS NOT DEPLOYING AS IT SHOULD, THE HANDLE WAS BACK AS FAR AS IT COULD ON THE METAL CANNULA. THE PHYSICIAN WAS FINALLY ABLE TO GET THE DEVICE TO DEPLOY BY USING FORWARD AND BACKWARD MOTION OF THE SHEATH. PATIENT OUTCOME: NO PATIENT IMPACT REPORTED. SG 30MAY2024 PATIENT/EVENT INFO - NOTES: THE FOLLOWING INFORMATION HAS BEEN REQUESTED & RECEIVED VIA EMAIL ON 30MAY2024. SG 30MAY2024 PLEASE SEE AVAILABLE ANSWERS BELOW. ALL OTHERS UNKNOWN. 1. WILL THE FACILITY BE REPORTING THIS TO A GOVERNMENT AGENCY (FDA, COMPETENT AUTHORITY, ETC.)? NO. 2. CONFIRM LOT: C2143471 CORRECT . 3. WILL THE PRODUCT BE RETURNED? PARTIALLY. 1. IF YES PLEASE USE THE FEDEX RETURN LABEL ALREADY PROVIDED. ONLY THE DELIVERY DEVICE OF PATIENT #3 WILL BE RETURNED . 4. CAN YOU PROVIDE ANY PATIENT INFORMATION (AGE, WEIGHT, GENDER, PRE-EXISTING CONDITIONS)? NO. 5. CONFIRM THE DESCRIPTION OF EVENT: THE PROXIMAL END OF THE STENT WAS NOT DEPLOYING AS IT SHOULD, THE HANDLE WAS BACK AS FAR AS IT COULD ON THE METAL CANNULA. THE PHYSICIAN WAS FINALLY ABLE TO GET THE DEVICE TO DEPLOY BY USING FORWARD AND BACKWARD MOTION OF THE SHEATH. CORRECT . 6. DID ANY UNINTENDED SECTION OF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19622153 ↗
• MalfunctionJun 6, 2024Off-Label Use; Off-Label Use

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 11-SEP-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19481065 ↗
• MalfunctionJun 5, 2024Off-Label Use; Off-Label Use

  DESCRIPTION OF EVENT: THE PROXIMAL END OF THE STENT WAS NOT DEPLOYING AS IT SHOULD, THE HANDLE WAS BACK AS FAR AS IT COULD ON THE METAL CANNULA. THE PHYSICIAN WAS FINALLY ABLE TO GET THE DEVICE TO DEPLOY BY USING FORWARD AND BACKWARD MOTION OF THE SHEATH. PATIENT OUTCOME: NO PATIENT IMPACT REPORTED. (B)(6) 2024. PATIENT/EVENT INFO - NOTES: THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA PHONE CALL ON 09MAY2024. (B)(6) 2024. 3.32 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO. 3.33 AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? STENT PLACEMENT. 3.34 DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? ROUTE 92 MEDICAL -8FR BASE .CAMP SHEATH SYSTEM. 3.35 WHAT WAS THE TARGET LOCATION FOR THE STENT? VENOUS SINUS. 3.36 WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? YES. 3.37 WAS THE DEVICE USED PERCUTANEOUSLY? YES. 3.38 WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORT BEFORE THE PROCEDURE, AS PER IFU? YES. 3.39 WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? NO. 3.40 WAS POST-DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? NO. 3.41 DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? BOSTON SCIENTIFIC V18 WIRE. 3.42 DID THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467342 ↗

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