Zilver VenaRecalls & reported problems across all models

We found 19 models of Zilver Vena by Cook Ireland Ltd in the FDA's device registry (GUDID). Together they are named in 108 adverse event reports in the FDA's MAUDE database, received between Dec 17, 2020 and Sep 18, 2025 — classified as 61 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (36 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 Vena problems

Zilver Vena models

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

• Zilver Vena G57449

  Stent, iliac vein
  27 reports
• Zilver Vena G57448

  Stent, iliac vein
  19 reports
• Zilver Vena G57445

  Stent, iliac vein
  11 reports
• Zilver Vena G57447

  Stent, iliac vein
  9 reports
• Zilver Vena G57455

  Stent, iliac vein
  7 reports
• Zilver Vena G57451

  Stent, iliac vein
  6 reports
• Zilver Vena G57454

  Stent, iliac vein
  6 reports
• Zilver Vena G57453

  Stent, iliac vein
  4 reports
• Zilver Vena G57434

  Stent, iliac vein
  3 reports
• Zilver Vena G57446

  Stent, iliac vein
  3 reports
• Zilver Vena G57437

  Stent, iliac vein
  2 reports
• Zilver Vena G57438

  Stent, iliac vein
  2 reports
• Zilver Vena G57443

  Stent, iliac vein
  2 reports
• Zilver Vena G57444

  Stent, iliac vein
  2 reports
• Zilver Vena G57433

  Stent, iliac vein
  1 report
• Zilver Vena G57435

  Stent, iliac vein
  1 report
• Zilver Vena G57439

  Stent, iliac vein
  1 report
• Zilver Vena G57441

  Stent, iliac vein
  1 report
• Zilver Vena G57442

  Stent, iliac vein
  1 report

Recent Zilver Vena adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionAug 18, 2025Failure to Advance; Activation, Positioning or Separation Problem; Failure to Advance; Activation, Positioning or Separation Problem

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 28-SEP-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22836201 ↗
• MalfunctionMar 11, 2025Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21571787 ↗
• InjuryFeb 11, 2025Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  PER REP - THE DELIVERY WAS FINE. ONCE THE STENT WAS DEPLOYED, IT DID NOT EXPAND FULLY, EVEN AFTER POST-DILATION. THEY HAD TO PUT IN A COMPETITIVE VENOUS STENT INSIDE THE COOK STENT TO KEEP IT FULLY EXPANDED. PREFIX ZVT7: 3.91 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO: PER REP. 3.92 DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? N/A, YES, NO: YES. IF YES, PLEASE SPECIFY: MAY THURNER. 3.93 PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (I.E. WAS THE ANATOMY TORTUOUS? WAS THE VESSEL FIBROTIC?) N/A, TORTUOUS, CALCIFIED, FIBROTIC, OTHER: OTHER. IF OTHER, PLEASE SPECIFY: COMPRESSED BECAUSE OF MAY THURNER. 3.94 WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? N/A, YES, NO: NO. 3.95 WAS THE DEVICE USED PERCUTANEOUSLY? N/A, YES, NO: YES. 3.96 WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? LEFT COMMON FEMORAL. 3.97 WAS THE ACCESS SITE JUGULAR OR FEMORAL? N/A, JUGULAR, FEMORAL OTHER. FEMORAL IF OTHER, PLEASE SPECIFY: 3.98 WHAT DISEASE PATHOLOGY WAS BEING TREATED? MAY THURNER, ACUTE OR CHRONIC OBSTRUCTION, RESTENOSIS, OTHER? MAY THURNER. IF OTHER, PLEASE SPECIFY. 3.99 WAS THE LESION APPROACHED VIA CONTRALATERAL OR IPSILATERAL? N/A, CONTRALATERAL, IPSILATERAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355222 ↗
• InjuryJan 24, 2025Device Endoleak; Device Endoleak

  ACCORDING TO THE INITIAL REPORTER, THE DELIVERY WAS FINE. ONCE THE STENT WAS DEPLOYED, IT DID NOT EXPAND FULLY, EVEN AFTER POST-DILATION. THEY HAD TO PUT IN A COMPETITIVE VENOUS STENT INSIDE THE COOK STENT TO KEEP IT FULLY EXPANDED.

  Patient problems: Clinical Endoleak

  MAUDE report 21228457 ↗
• 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 ↗
• InjuryAug 22, 2024Migration; Migration

  THE PRACTICE WAS NOTIFIED OF A STENT MIGRATION INVOLVING A COOK ZILVER VENA STENT (REF ZVT7-35-80-16-100, G57448, LOT C1769829) WHICH WAS PLACED BY DR (B)(6) ON (B)(6) 2021. SURVEILLANCE ULTRASOUNDS IN OUR OFFICE LAST IDENTIFIED THE STENT VISUALIZED IN THE COMMON ILIAC ARTERY (TARGET VESSEL) ON 8DEC2022. THE PATIENT FAILED TO FOLLOW UP WITH OUR PRACTICE AFTER THAT DATE. THE STENT WAS INCIDENTALLY FOUND IN THE HEART ON OR AROUND 7JUN2024 DURING A FEVER WORKUP THE PATIENT UNDERWENT AT HARTFORD HEALTHCARE. REMOVAL WAS ATTEMPTED ENDOVASCULARLY BUT ULTIMATELY ACHIEVED THROUGH OPEN THORACOTOMY DUE TO ADHERENCE TO THE TRICUSPID VALVE, AND NECESSITATING A TRICUSPID VALVE REPLACEMENT. TO OUR BEST KNOWLEDGE, THE PATIENT IS ALIVE AT THIS TIME. -ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? -DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? - IF YES, PLEASE SPECIFY: -PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (IE WAS THE ANATOMY TORTUOUS? WAS THE VESSEL FIBROTIC?) N/A, TORTUOUS, CALCIFIED, FIBROTIC, OTHER - IF OTHER, PLEASE SPECIFY: -WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? -WAS THE DEVICE USED PERCUTANEOUSLY? -WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? -WAS THE

  Patient problems: Fever

  MAUDE report 20041322 ↗
• InjuryAug 22, 2024Migration; Migration

  THE PRACTICE WAS NOTIFIED OF A STENT MIGRATION INVOLVING A COOK ZILVER VENA STENT (REF ZVT7-35-80-16-100, G57448, LOT C1769829) WHICH WAS PLACED BY DR (B)(6) ON (B)(6) 2021. SURVEILLANCE ULTRASOUNDS IN OUR OFFICE LAST IDENTIFIED THE STENT VISUALIZED IN THE COMMON ILIAC ARTERY (TARGET VESSEL) ON (B)(6) 2022. THE PATIENT FAILED TO FOLLOW UP WITH OUR PRACTICE AFTER THAT DATE. THE STENT WAS INCIDENTALLY FOUND IN THE HEART ON OR AROUND (B)(6) 2024 DURING A FEVER WORKUP THE PATIENT UNDERWENT AT HARTFORD HEALTHCARE. REMOVAL WAS ATTEMPTED ENDOVASCULARLY BUT ULTIMATELY ACHIEVED THROUGH OPEN THORACOTOMY DUE TO ADHERENCE TO THE TRICUSPID VALVE, AND NECESSITATING A TRICUSPID VALVE REPLACEMENT. TO OUR BEST KNOWLEDGE, THE PATIENT IS ALIVE AT THIS TIME. **PLEASE PROVIDE THE ORIGINATOR A LIST OF ANY ADDITIONAL MANUFACTURER QUESTIONS REQUIRED FOR INVESTIGATION. (B)(4) 24JUL2024. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? IF YES, PLEASE SPECIFY: PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (IE WAS THE ANATOMY TORTUOUS? WAS THE VESSEL FIBROTIC?) N/A, TORTUOUS, CALCIFIED, FIBROTIC, OTHER IF OTHER, PLEASE SPECIFY: WAS A STENT PREVIOUSLY PLACED DURIN

  Patient problems: Fever

  MAUDE report 20034341 ↗
• 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 ↗
• MalfunctionJul 9, 2024Structural Problem; Structural Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 22-JAN-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19701602 ↗
• MalfunctionMay 16, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ALREADY HAD A STENT ON THE OTHER SIDE THAT WAS PLACED BY A DIFFERENT PHYSICIAN AT A DIFFERENT LAB (MEDTRONIC ABRE STENT). PATIENT OUTCOME: THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA EMAIL ON 19JUN2023. SG 19JUN2023. 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? AN ADDITIONAL STENT WAS USED INSIDE THE ELONGATED STENT. 4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. 5. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. 6. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PATIENT/EVENT INFO - NOTES: THE FOLLOWING INFORMATION HAS BEEN REQUESTED VIA EMAIL ON 15JUN2023 / 19JUN2023. SG 19JUN2023. 3.91 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO. 3.92 DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? N/A, YES, NO. IF YES, PLEASE SPECIFY: 3.93 PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (I.E. WAS THE ANATOMY TORTUOUS? WAS THE VESSEL FIBROTIC?) N/A, TORTUOUS, CALCIF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19329172 ↗
• MalfunctionSep 6, 2023Activation Problem; Activation Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 25-APR-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17694984 ↗
• MalfunctionSep 5, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: TWO STENTS WERE PLACED DURING A VENAGRAM PROCEDURE. THE SECOND STENT LOOKED MANGLED AND KINKED WHEN PLACING AND DID NOT OPEN AND SMOOTH OUT AS NORMAL. THE PHYSICIAN DID AN ANGIO WITH A 14 ATLAS BALLOON. WHILE IT DID HELP TO OPEN AND STRAIGHTEN, THE STENT WAS STILL NOT AS OPEN AND STRAIGHT AS IT SHOULD BE. THIS FILE WILL CAPTURE THE USE OF A 8FR ANSEL ACCESS SHEATH. 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. PREFIX ZVT7 3.91 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? YES. SEE ATTACHMENTS. 3.92 DID THE PATIENT HAVE PRE-EXISTIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682016 ↗
• MalfunctionAug 22, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 19-SEPT-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17594480 ↗
• MalfunctionAug 17, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 18-DEC-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17563750 ↗

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