Zilver 518 G43783Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10827002437835), received between Oct 28, 2021 and May 23, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionMay 10, 2024Off-Label Use; Off-Label Use

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 27-AUG-2024

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19284368 ↗
• MalfunctionAug 18, 2022Off-Label Use; Off-Label Use

  SUPPLEMENTAL MDR BEING SUBMITTED DUE TO COMPLETION OF LAB EVALUATION ON 25-AUG-2022: (B)(4). USED. VISUAL INSPECTION - RED SAFETY TAB NOT RETURNED, THE BLUE OTHER SHEATH IS SEPERATED AT THE HANDLE. FUNCTIONAL - DEVICE FLUSHES WITHOUT ISSUE. A 0.018INCH WIRE GUIDE PASSES WITH NO ISSUE. (B)(4). USED. VISUAL INSPECTION - RED SAFETY TAB NOT RETURNED. BLUE SHEATH IS SEPERATED AT THE HANDLE. FUNCTIONAL - DEVICE FLUSHES WITHOUT ISSUE, A 0.018 INCH WIRE GUIDE PASSES WITH NO ISSUES. (B)(4). UNUSED. RETURNED IN ORIGINAL PACKAGING. VISUAL - RED SAFETY TAB RETURNED IN PLACE ON DEVICE. NO DAMAGE OBSERVED. FUNCTIONAL - DEVICE FLUSHES WITH NO ISSUE. 0.018INCH WIRE GUIDE PASSES WITH NO ISSUES. STENT DEPLOYS WITH NO ISSUE. (B)(4). UNUSED. RETURNED IN ORIGINAL PACKAGING. VISUAL - RED SAFETY TAB RETURNED IN PLACE ON DEVICE. NO DAMAGE OBSERVED. FUNCTIONAL - DEVICE FLUSHES WITH NO ISSUE. 0.018INCH WIRE GUIDE PASSES WITH NO ISSUES. STENT DEPLOYS WITH NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15248846 ↗
• InjuryNov 12, 2021Break; Break

  "SOME PORTION OF THE DELIVERY SYSTEM BROKE OFF INTO THE PATIENT. WHEN IT BROKE OFF, THE DOCTOR FELT COMFORTABLE THAT THE PATIENT "WOULD BE FINE" AND DIDN'T ATTEMPT RETRIEVAL DURING THE PROCEDURE." LAB EVALUATION COMPLETED ON 26-NOV-2020, THE FOLLOWING OBSERVATIONS WERE NOTED: DEVICE COULD NOT BE FLUSHED. 0.018 INCH WIRE GUIDE ADVANCED THROUGH DEVICE WITH RESISTANCE. COULD NOT ADVANCE WIRE GUIDE BEYOND APPROX. 107CM. HANDLE MOVED TO HUB WITH A LOT OF RESISTANCE. INNER CATHETER PROTRUDES THROUGH THE SHEATH AT APPROX. 2.5CM FROM DISTAL END OF SHEATH WHEN HANDLE WAS MOVED TO HUB. PATIENT OUTCOME: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? YES. IF YES, PLEASE DESCRIBE. SEE EVENT DESCRIPTION. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? IF YES, PLEASE DESCRIBE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? IF YES, PLEASE DESCRIBE. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? HAS THE COMPLAINANT REPORTE

  Patient problems: Foreign Body In Patient

  MAUDE report 12802071 ↗
• MalfunctionOct 28, 2021Off-Label Use; Off-Label Use

  THE CATHETER PORTION OF THE FLEXOR CAME DETACHED FROM THE DEPLOYMENT DEVICE. WHEN HE WENT TO PULL BACK TO DEPLOY IT, IT DETACHED. THE STENT WAS NOT ABLE TO BE DEPLOYED. THEY PULLED THE DELIVERY CATHETER OUT OVER THE WIRE. THE STENT WAS STILL IN THE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. OFF LABEL USE: ATTEMPTED DELIVERY IN THE RIGHT SFA. PATIENT OUTCOME: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? -NO IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? -NO DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? -NO IF YES, PLEASE DESCRIBE. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? -NO IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. 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. GENERAL QUESTIONS FOR COMPLAINT OCCURRING DURING USE, REQUEST THE FOLLOWING: WHERE WAS THE ACCESS SITE? -LEFT GROIN WHAT WAS THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12710554 ↗