Zilver Vena G57454Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002574547), received between Mar 18, 2021 and Aug 22, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionApr 28, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE 26-JUN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16830781 ↗
• MalfunctionApr 28, 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 07-JUL-2023

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16830757 ↗
• MalfunctionApr 28, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON THE 26-JUN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16830735 ↗
• MalfunctionFeb 27, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION, "UPON DEPLOYMENT OF THE DEVICE, THE INITIAL UNSHEATHING OF THE STENT WAS REPORTED TO BE DIFFICULT AND MORE FORCE WAS NEEDED THAN REQUESTED. IT FELT LIKE A POP. HOWEVER, WILL A BIT MORE FORCE, IT DEPLOYED." PATIENT OUTCOME: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED: DID THE PATIENT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE? NO. PLEASE SPECIFY DELAY OR ANY ADDITIONAL PROCEDURE(S) 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. PATIENT/EVENT INFO NOTES: 3.9. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? YES, 3.92. DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? N/A. IF YES, PLEASE SPECIFY: 3.93, PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (I.E. WAS THE ANATOMY TORTUOUS? IT WAS NOT TORTUOUS, BUT WAS HEAVILY COMPRESSED WAS THE VESSEL FIBROTIC?) N/A, TORTUOUS, CALCIFIED, FIBROTIC, OTHER NO. IF O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16443951 ↗
• MalfunctionMar 18, 2021No Display/Image; No Apparent Adverse Event; No Display/Image; No Apparent Adverse Event

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION WITH THE DISTRICT MANAGER:THE DEVICE PERFORMED AS IT SHOULD. THERE WAS NO ISSUES WITH THE DEVICE PERFORMANCE AND THE PROCEDURE WENT WELL. THE PHYSICIAN WANTED TO REPORT THAT DURING AND UNDISCLOSED PROCEDURE THE MARKERS UNDER FLUOROSCOPY WERE VERY DIFFICULT TO SEE. HE IN FACT STATED THIS AS AN IN GENERAL FEEDBACK EACH TIME HE USES THE PRODUCT. THE PHYSICIAN BROUGHT IT TO THE DISTRICT MANAGERS ATTENTION AS SHE WAS PRESENT DURING THIS PROCEDURE.PATIENT/EVENT INFO - NOTES: ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? YES. DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? YESIF YES, PLEASE SPECIFY:MORBID OBESITY, DVT. PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (I.E. WAS THE ANATOMY TORTUOUS? WAS THE VESSEL FIBROTIC?) N/A, TORTUOUS, CALCIFIED, FIBROTIC, OTHERIF OTHER, PLEASE SPECIFY ACUTE DVT OTHERWISE N/A. WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? NO. WAS THE DEVICE USED PERCUTANEOUSLY? YES. WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? LESSER SAPHENOUS VEIN. WAS THE ACCESS SITE JUGULAR OR FEMORAL? OTHERIF OTHER, PLEASE SPECIFY: LESSER SAPHENOUS VEIN. WHAT DISEASE PATHOLOGY WAS BEING TREATED?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11518085 ↗