Stellarex AB35SX040200135Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813132026455), received between Aug 11, 2020 and Aug 11, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Insert” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2020Difficult to Insert; Difficult to Insert

  THE STELLAREX DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED AND A SEVERELY TORTUOUS PROXIMAL CFA. THE PHYSICIAN ATTEMPTED TO LOAD THE STELLAREX OVER THREE DIFFERENT SIZE GUIDE WIRES (014, 018, 035), BUT WAS UNABLE TO PASS ALL THE WAY THROUGH THE 6F TERUMO DESTINATION SHEATH. THE STELLAREX WAS REMOVED FROM THE 035 GUIDE WIRE, WHICH REMAINED IN THE PATIENT. THE PHYSICIAN THEN REMOVED THE INTRODUCER SHEATH AND REPLACED IT WITH A NEW INTRODUCER SHEATH. AT THAT POINT, A NEW STELLAREX WAS LOADED OVER THE EXISTING 035 GUIDE WIRE AND WAS ABLE TO PASS THROUGH THE NEW INTRODUCER SHEATH WITH NO ISSUES. WHEN THE FIRST STELLAREX WAS REMOVED FROM THE PATIENT, THE PHYSICIAN DID NOT ATTEMPT TO LOAD THE NEW STELLAREX THROUGH THE FIRST INTRODUCER SHEATH. THEREFORE, IT IS UNKNOWN IF THE STELLAREX WAS UNABLE TO PASS DUE TO AN OCCLUDED GUIDE WIRE LUMEN (PREVENTING THE STELLAREX TO ADVANCE PAST THE INTRODUCER SHEATH) OR AN OCCLUDED INTRODUCER SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10394216 ↗