Zilver 635 G43826Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002438269), received between Oct 12, 2016 and Sep 5, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Expiration Issue” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  STENT WOULD NOT ADVANCE THROUGH THE ANSEL SHEATH AND WAS STUCK INSIDE SHEATH TO REMOVE. SHEATH AND STENT WERE REMOVED TOGETHER. NEW ANSEL AND A 518 STENT WERE INSERTED TO FINISH THE CASE. DURING INSERTION AND PLACEMENT. 1. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? UNPACKING OR PREPARATION OF THE DEVICE, INSERTION, STENT PLACEMENT, REMOVING THE INTRODUCER. 2. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 6X45 ANSEL. 3. WHAT WAS THE TARGET LOCATION FOR THE STENT? SFA. 4. WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? N/A, YES, NO. YES. 5. WAS THE DEVICE USED PERCUTANEOUSLY? N/A, YES, NO. YES. 6. WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORT BEFORE THE PROCEDURE, AS PER IFU? N/A, YES, NO. YES. 7. WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? N/A, YES, NO. YES. 8. WAS POST-DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? N/A, YES, NO. N/A. 9. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHILIC)? HYDRO ST. 10. DID THE PATIENT EXHIBIT DIFFICULT OR ALTERED ANATOMY (IF ALTERED PLEASE SPECIFY HOW IT IS ALTERED)? N/A, TORTUOUS, CALCIFIED, ALTERED. CALCIFIED. 11. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977948 ↗
• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAS HAD NUMEROUS CTS AND A TOTAL OF 4 SECONDARY INTERVENTIONS THROUGHOUT PARTICIPATION IN THIS STUDY. TO SIMPLIFY THESE CTS (AS RELATED TO THIS EVENT), PLEASE SEE THE TABLE UPLOADED AS AN ATTACHED FILE THE TABLE PROVIDES THE DATE OF THE IMAGING, THE NUMBER OF DAYS POST-PROCEDURE, THE MAXIMUM ANEURYSM DIAMETER AND PRESENCE OF AN ENDOLEAK (AS REPORTED BY THE CLINICAL STUDY SITE OR THE CORE LABORATORY). ALSO INCLUDED IS THE SECONDARY INTERVENTIONS, THE INDICATION FOR THEM AND THE TREATMENTS. A CT DATED (B)(6) 2021 REVEALED AN ENLARGING ANEURYSM. THE CLINICAL STUDY SITE WAS UNABLE TO IDENTIFY AN ENDOLEAK AND REPORTED THE MAXIMUM ANEURYSM DIAMETER WAS 73MM. THE CORE LABORATORY EVALUATION OF THE CT IDENTIFIED A DEFINITE ENDOLEAK BUT THE SOURCE COULD NOT BE DETERMINED AND WAS LISTED AS AN UNKNOWN ENDOLEAK. A SECOND CT SCAN DATED (B)(6) /2021 WAS COMPLETED. THE SITE AGAIN COULD NOT IDENTIFY AN ENDOLEAK, BUT CONTINUED ANEURYSM ENLARGEMENT, NOW 77MM, LED THE SITE TO SCHEDULE A SECONDARY INTERVENTION. CORE LABORATORY EVALUATION OF THE CT AGAIN REVEALED AN UNKNOWN TYPE ENDOLEAK. ON (B)(6) 2021 (1705 DAYS POST-PROCEDURE) THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO PLACE A PRO

  Patient problems: Aneurysm

  MAUDE report 11998318 ↗
• InjuryJun 15, 2021Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAS HAD NUMEROUS CTS AND A TOTAL OF 4 SECONDARY INTERVENTIONS THROUGHOUT PARTICIPATION IN THIS STUDY. TO SIMPLIFY THESE CTS (AS RELATED TO THIS EVENT), PLEASE SEE THE TABLE UPLOADED AS AN ATTACHED FILE THE TABLE PROVIDES THE DATE OF THE IMAGING, THE NUMBER OF DAYS POST-PROCEDURE, THE MAXIMUM ANEURYSM DIAMETER AND PRESENCE OF AN ENDOLEAK (AS REPORTED BY THE CLINICAL STUDY SITE OR THE CORE LABORATORY). ALSO INCLUDED IS THE SECONDARY INTERVENTIONS, THE INDICATION FOR THEM AND THE TREATMENTS. A CT DATED (B)(6) 2021 REVEALED AN ENLARGING ANEURYSM. THE CLINICAL STUDY SITE WAS UNABLE TO IDENTIFY AN ENDOLEAK AND REPORTED THE MAXIMUM ANEURYSM DIAMETER WAS 73MM. THE CORE LABORATORY EVALUATION OF THE CT IDENTIFIED A DEFINITE ENDOLEAK BUT THE SOURCE COULD NOT BE DETERMINED AND WAS LISTED AS AN UNKNOWN ENDOLEAK. A SECOND CT SCAN DATED (B)(6) 2021 WAS COMPLETED. THE SITE AGAIN COULD NOT IDENTIFY AN ENDOLEAK, BUT CONTINUED ANEURYSM ENLARGEMENT, NOW 77MM, LED THE SITE TO SCHEDULE A SECONDARY INTERVENTION. CORE LABORATORY EVALUATION OF THE CT AGAIN REVEALED AN UNKNOWN TYPE ENDOLEAK. ON (B)(6) 2021 (1705 DAYS POST-PROCEDURE) THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO PLACE A PROX

  Patient problems: Aneurysm; Thrombosis/Thrombus

  MAUDE report 11997743 ↗
• MalfunctionAug 13, 2019Use of Device Problem; Use of Device Problem

  AS REPORTED TO CUSTOMER RELATIONS "THE EXPIRED DEVICE WAS IMPLANTED IN THE RIGHT EXTERNAL ILIAC. THE CUSTOMER MISREAD THE EXPIRATION DATE ON THE PACKAGING AND DID NOT REALIZE THAT THE DEVICE WAS EXPIRED UNTIL THE PROCEDURE WAS COMPLETED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8888136 ↗
• MalfunctionOct 12, 2016Device Expiration Issue; Device Expiration Issue

  THE STENT WAS PLACED, IT WAS THEN NOTED THE STENT HAD EXPIRED. THE CUSTOMER HAS NO ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6019831 ↗