Zilver Flex 35 G50170Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002501703), received between Jul 25, 2017 and May 20, 2022 — 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 18, 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.

• MalfunctionMay 20, 2022Premature Activation; Off-Label Use; Premature Activation; Off-Label Use

  AS REPORTED, DURING A PROCEDURE INVOLVING PLACEMENT OF A STENT WITHIN A LESION IN THE SUPERFICIAL FEMORAL ARTERY, A ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT PARTIALLY DEPLOYED. THE HEAVILY CALCIFIED LESION WAS CROSSED AND PRE-DILATED WITH AN UNKNOWN BALLOON. THE COMPLAINT DEVICE WAS THEN INTRODUCED INTO THE PATIENT OVER AN UNKNOWN 0.035-INCH WIRE AND THROUGH AN UNSPECIFIED 6 FRENCH, 45-CENTIMETER SHEATH; HOWEVER, THE USER REPORTED THAT THE DELIVERY DEVICE SEEMED TO BE CAUGHT UP IN THE SUB-INTIMA. THE DEVICE WAS REMOVED FROM THE PATIENT, AT WHICH POINT THE USER NOTICED THAT THE STENT WAS PARTIALLY DEPLOYED. AT NO TIME WAS ANY PART OF THE COMPLAINT DEVICE/STENT LEFT IN THE PATIENT. ANOTHER STENT OF THE SAME SIZE WAS THEN DEPLOYED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14455488 ↗
• MalfunctionJan 11, 2021Off-Label Use; Difficult to Advance; Off-Label Use; Difficult to Advance

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11147863 ↗
• MalfunctionJul 25, 2017Sticking; Sticking

  IT WAS REPORTED THAT THE ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT GOT STUCK AND PULLED OUT ON THE WIRE. THE CUSTOMER REPORTED THAT IT LOOKED FINE OUT OF THE PACKAGING. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER STENT. THIS PROBLEM DID NOT CREATE THE NEED FOR ANY INTERVENTION OR ADDITIONAL PROCEDURES. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6740944 ↗