Zilver 635 G43833Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002438337), received between Oct 5, 2018 and Oct 30, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (2 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.

• MalfunctionOct 30, 2024Off-Label Use; Off-Label Use

  THE CATHETER SEPARATED FROM THE HUB/VALVE AREA. THE STENT DID NOT UNSHEATHE, AND THE USER WAS ABLE TO REMOVE THE DEVICE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER SIMILAR DEVICE (ZILVER 635 9X80) WITHOUT INTERVENTIONAL PROCEDURES OR ADVERSE EFFECTS. PATIENT OUTCOME: NO UNINTENDED SECTION OF THIS DEVICE REMAINS INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT UNDERGO PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE. PATIENT/EVENT INFO - NOTES: INFORMATION REQUESTED/ANSWERED DURING CALL: ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO WAS THIS A PRIMARY PROCEDURE OR A RECURRENT PROCEDURE? PRIMARY WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? NA WAS THE DEVICE USED PERCUTANEOUSLY? YES WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? ILIAC ACCESS DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? UNKNOWN, BUT THE SHEATH IS PACKAGED WITH THE DEVICE BEING RETURNED. WHAT WAS THE TARGET LOCATION FOR THE STENT? TRANSVERSE SINUS WAS THE DEVICE FLUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20565677 ↗
• MalfunctionFeb 2, 2023Off-Label Use; Off-Label Use

  SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED TO CAPTURE LAB EVALUATION CONDUCTED ON 25-MAY-2023 AND ALSO DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS ON THE 26-MAY-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283469 ↗
• MalfunctionOct 5, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  MDR SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: "STENT SHORTENING/ COMPRESSION DURING DEPLOYMENT". TWO DEVICES WERE PLACED IN THE PATIENT. IT IS UNKNOWN IF ONE DEVICE IS TOO LONG, OR ONE DEVICE IS TOO SHORT; HOWEVER, ONE DEVICE IS THE INCORRECT LENGTH. TWO LOT# WERE IDENTIFIED WHICH TRIGGERED AN ADDITIONAL REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7937668 ↗