Zilver Vena G57451Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002574516), received between May 24, 2022 and Sep 18, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Improper or Incorrect Procedure or Method; Difficult to Advance; Improper or Incorrect Procedure or Method; Difficult to Advance

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A SPECIES STENTING PROCEDURE IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57451, WAS TO BE USED. PRIOR TO PROCEDURE, THE PHYSICIAN WAS TRYING TO ADVANCE THE STENT OVER THE WIRE AND HAD DIFFICULTY AND THEN THE STENT WOULD NOT COME BACK OFF OF THE WIRE. THE PHYSICIAN PULLED SO HARD THAT THE STENT STARTED TO DEPLOY ON THE WIRE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085699 ↗
• InjuryDec 18, 2024Migration; Migration

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 15-JUL-25.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20968275 ↗
• MalfunctionJul 18, 2024Off-Label Use; Difficult to Remove; Off-Label Use; Difficult to Remove

  ABLE TO DEPLOY THE STENT, BUT WHEN THEY WENT TO REMOVE THE DELIVERY CATHETER IT WAS STUCK ON THE WIRE, THERE WAS SOME TENSION SO WHEN THEY WERE ABLE TO PULL IT OUT, THE TIP OF THE CATHETER BROKE OFF INSIDE THE PATIENT. THEY WERE ABLE TO USE A 5FR KMP CATHETER OVER THE WIRE AND IT SNAGGED THE PIECE THAT BROKE OFF. THE CATHETER, WIRE AND BROKEN PIECE WERE ALL ABLE TO BE PULLED AT THE SAME TIME. NO PATIENT IMPACT REPORTED. 3.91 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? YES, FINAL IMAGES OF THE PROCEDURE. 3.93 PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL? NORMAL, EXCEPT THERE WAS DVT WHERE THE STENT WAS GOING TO BE PLACED, 1ST STEP REMOVED BLOOD CLOT IN THE VESSEL THEN PLACED THE STENT. 3.94 WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? NO 3.95 WAS THE DEVICE USED PERCUTANEOUSLY? YES 3.96 WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? POPLITEAL VEIN 3.97 WAS THE ACCESS SITE JUGULAR OR FEMORAL? OTHER, POPLITEAL VEIN 3.98 WHAT DISEASE PATHOLOGY WAS BEING TREATED? MAY THURNER 3.99 WAS THE LESION APPROACHED VIA CONTRALATERAL OR IPSILATERAL? IPSILATERAL 3.100 WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? YES 3.101 WHAT WAS THE TARGET LOCATION FOR T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19770352 ↗
• MalfunctionFeb 3, 2023Material Too Rigid or Stiff; Activation, Positioning or Separation Problem; Material Too Rigid or Stiff; Activation, Positioning or Separation Problem

  SUPPLEMENTAL FOLLOW-UP MDR REPORT IS BEING SUBMITTED DUE TO THE RECEIPT AND EVALUATION OF THE COMPLAINT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 16289010 ↗
• InjuryMay 24, 2022Migration; Migration

  AS REPORTED TO CUSTOMER RELATIONS VIA COMPLAINT EMAIL "DURING THE PROCEDURE HE USED ALPHA BACK. I ASKED HIM IF THAT DEVICE CONTRAINDICATED IN A STENT. HE DECLARED HE DIDN¿T KNOW WHETHER IT WAS OR WASN¿T. I LATER LEARNED THAT THE ALPHABACK REP WAS THERE FOR THE CASE. HE PASSED THE THROMBECTOMY DEVICE THROUGH THE STENT AND CLEARED SOME CLOT OUT OUT AND IMAGES SHOW IMPROVEMENT BUT CLOT WAS NOTED IN THE IVC FILTER. HE WENT BACK IN WITH THE THROMBECTOMY DEVICE TO CLEAR OUT THE CLOT IN THE FILTER. HE STATED HE TURNED HAD THE MACHINE AS HE PUSHED THE DEVICE UP. AFTER HE WAS DONE HE PULLED THE DEVICE BACK AND NOTED THE STENT WAS POTENTIALLY FRACTURED/ MIGRATED/ AND/ OR FOLDED ON ITSELF. CT SCAN LATER CONFIRMED THAT THE STENT WAS AT LEAST FOLDED ON ITSELF." NOTE: ZILVER VENA DEPLOYED ON APRIL 20TH BY DR (B)(6) AT LINCOLN (B)(6). GOT THE CALL FROM DR (B)(6) AT 3:38PM. HE SAID THE STENT WENT DOWN AND CLOTTED OFF. THE LOT NUMBER IN THAT STENT IS C1846966. HIS COMPLAINT WAS THAT THE STENT MIGRATED INTO THE IVC DURING HIS THROMBECTOMY PROCEDURE DONE ON (B)(6) 2022. ANSWER TO ADDITIONAL QUESTION: THERE IS NO COMPLAINT DEVICE TO RETURN. THE COMPLAINT WAS IATROGENIC MIGRATION OF A STENT IMPLANT 6 D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14492189 ↗
• InjuryMay 24, 2022Fracture; Migration; Fracture; Migration

  AS REPORTED TO CUSTOMER RELATIONS VIA COMPLAINT EMAIL "DURING THE PROCEDURE HE USED ALPHA BACK. I ASKED HIM IF THAT DEVICE CONTRAINDICATED IN A STENT. HE DECLARED HE DIDN¿T KNOW WHETHER IT WAS OR WASN¿T. I LATER LEARNED THAT THE ALPHABACK REP WAS THERE FOR THE CASE. HE PASSED THE THROMBECTOMY DEVICE THROUGH THE STENT AND CLEARED SOME CLOT OUT AND IMAGES SHOW IMPROVEMENT BUT CLOT WAS NOTED IN THE IVC FILTER. HE WENT BACK IN WITH THE THROMBECTOMY DEVICE TO CLEAR OUT THE CLOT IN THE FILTER. HE STATED HE TURNED HAD THE MACHINE AS HE PUSHED THE DEVICE UP. AFTER HE WAS DONE HE PULLED THE DEVICE BACK AND NOTED THE STENT WAS POTENTIALLY FRACTURED/ MIGRATED/ AND/ OR FOLDED ON ITSELF. CT SCAN LATER CONFIRMED THAT THE STENT WAS AT LEAST FOLDED ON ITSELF." NOTE: ZILVER VENA DEPLOYED ON (B)(6) BY (B)(6) (C20413-1). GOT THE CALL FROM (B)(6). HE SAID THE STENT WENT DOWN AND CLOTTED OFF. THE LOT NUMBER IN THAT STENT IS C1846966. HIS COMPLAINT WAS THAT THE STENT MIGRATED INTO THE IVC DURING HIS THROMBECTOMY PROCEDURE DONE ON (B)(6) 2022. ANSWER TO ADDITIONAL QUESTION: THERE IS NO COMPLAINT DEVICE TO RETURN. THE COMPLAINT WAS IATROGENIC MIGRATION OF A STENT IMPLANT 6 DAYS AFTER DEPLOYMENT. THIS WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 14488945 ↗