Zilver 635 G43843Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002438436), received between Aug 4, 2022 and Jan 12, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Off-Label Use

  IT WAS REPORTED THAT AFTER THE STENT WAS DEPLOYED DURING A VENOUS STENT PLACEMENT, A PIECE OF THE INNER CATHETER BROKE OFF. THEY USED A SNARE TO PULL OUT THE PIECE OF THE BROKEN CATHETER. THERE WAS NO DELAY OR ADDITIONAL PROCEDURE. NO REPORTED ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24034674 ↗
• InjuryJan 9, 2026Off-Label Use

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 17-FEB-2026. AFTER DEPLOYING THE STENT, A PIECE OF THE INNER CATHETER BROKE OFF. THEY USED A SNARE TO PULL OUT THE PIECE OF THE BROKEN CATHETER. 1. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 6 FRENCH BUT NOT SURE OF THE EXACT NAME. 2. WHAT WAS THE TARGET LOCATION FOR THE STENT? NOT ANSWERED. 3. CAN YOU PLEASE CLARIFY WHAT PIECE OF THE INNER CATHETER BROKE OFF? IF YOU CAN SHARE A IMAGE, IT WILL BE VERY HELPFUL FOR INVESTIGATION. VENOUS SINUS. THE INNER WIRE CANNULA BROKE. 4. DID THE USER OBSERVE ANY ISSUE THAT MAY CAUSE THIS TO HAPPEN? NO. 5. WAS THE DEVICE USED PERCUTANEOUSLY? YES. 6. WHAT WAS THE ACCESS SITE CHOSEN? FEMORAL VEIN. 7. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHILIC)? .035 BENTSON. 8. WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? NO. 9. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED, CALCIFIED, FIBRIOTIC)? (IF ALTERED PLEASE INDICATE THE PROCEDURE TYPE). VERY TORTUOUS. 10. WAS THE APPROACH IPSILATERAL OR CONTRALATERAL? N/A, ISPILATERAL, CONTRALATERAL (IF CONTRALATERAL, WAS THE BIFURCATION ANGLE STEEP? N/A, YES, NO). N/A. 11. WERE A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24027293 ↗
• MalfunctionAug 4, 2022Off-Label Use; Off-Label Use

  REPORTED BY THE DM ON BEHALF OF THE CUSTOMER VIA EMAIL - ZILVER STENT DID NOT DEPLOY PROPERLY. OFF LABEL BASED ON USE FOR TRANSVERSE SINUS STENTING. THE FOLLOWING HAS BEEN REQUESTED.- (B)(6) 2022 DID ANY UNINTENDED SECTION OF THE DEVICE REMA.IN INSIDE THE PATIENT¿S BODY? IF YES, PLEASE DESCRIBE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? 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 REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE THIS OCCURRENCE? THE FOLLOWING HAS BEEN ANSWERED.- (B)(6) 2022 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? A. IF YES, PLEASE DESCRIBE. STENT WAS LEFT BUT DELIVERY SYSTEM WAS REMOVED. 2. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. 3. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. A. I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15163656 ↗