TracStar™ Large Distal Platform ICAC088105Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812212030139), received between Nov 19, 2019 and May 13, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A THROMBECTOMY WAS PERFORMED TO TREAT OCCLUSIONS IN THE LEFT SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). ONE OCCLUSION WAS OBSERVED IN THE M1 MCA, ALONG WITH MULTIPLE OCCLUSIONS WITHIN THE M3 MCA. THE TRACSTAR 088 LDP 105CM CATHETER WAS DELIVERED OVER A GUIDEWIRE AND 027 MICROCATHETER TO THE DISTAL INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN THEN ADVANCED A REPERFUSION CATHETER AND 3X20MM STENT RETRIEVER THROUGH TRACSTAR AND USED THESE DEVICES TO REMOVE THE CLOTS FROM THE M1 MCA AND M3 MCA. MULTIPLE ATTEMPTS WERE REQUIRED TO REMOVE ALL OF THE CLOTS AND THE TRACSTAR CATHETER WAS REPOSITIONED DURING THESE ATTEMPTS. REPERFUSION WAS ACHIEVED AFTER OVER AN HOUR OF TREATMENT WITH A FINAL TICI 2B SCORE. FOLLOW UP MRI PERFORMED THE NEXT DAY FOUND A COMPLETE OCCLUSION OF THE LEFT CAROTID ARTERY AND A FULL HEMISPHERIC STROKE THAT REQUIRED TREATMENT VIA A HEMICRANIECTOMY. THE PHYSICIAN REVIEWED THE FINAL ANGIOGRAPHIC RUNS OF THE THROMBECTOMY FOR POTENTIAL CAUSES OF THE OCCLUSION AND NOTED SMALL MICROLESIONS IN THE ICA, BUT SAW NO CLEAR VESSEL DISSECTION OR INJURY THAT WOULD HAVE CONTRIBUTED TO THE EVENT. AT THIS TIME, THE CAUSE OF THE ICA OCCLUSION IS UNKNOWN.

  Patient problems: Thrombus

  MAUDE report 10054294 ↗
• InjuryNov 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION IN THE M2/M3 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE IMPERATIVE CARE TRACSTAR 088 LDP WAS USED AS THE ACCESS CATHETER TO SUPPORT DELIVERY OF A PENUMBRA 3MAX REPERFUSION CATHETER AND A GUIDEWIRE. ALL THREE DEVICES WERE ADVANCED TO THE CAVERNOUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA), THEN THE PHYSICIAN CONTINUED TO ADVANCE THE 3MAX AND GUIDEWIRE TO THE SITE OF THE OCCLUSION. ASPIRATION WAS SUCCESSFULLY PERFORMED USING THE 3MAX AND IT WAS REMOVED FROM THE PATIENT. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO TREAT CAROTID ATHEROSCLEROSIS NOTED EARLIER IN THE PROCEDURE AND PULLED THE TRACSTAR BACK TO PERFORM A CONTRAST IMAGING RUN. ON THE IMAGING RUN, THE PHYSICIAN NOTED A CAROTID CAVERNOUS FISTULA (CCF) THAT WASN'T PRESENT AT THE START OF THE PROCEDURE. AS THE TRACSTAR, 3MAX, AND GUIDEWIRE WERE ALL ADVANCED THROUGH THE CAVERNOUS ICA IT IS POSSIBLE THAT ONE OF THESE DEVICES CAUSED THE CCF. THE PHYSICIAN CONTINUED THE PROCEDURE TO TREAT THE CAROTID ATHEROSCLEROSIS AND DECIDED THAT THE CCF DID NOT REQUIRE IMMEDIATE TREATMENT AS IT WAS SLOW FILLING AND ASYMPTOMATIC. WHILE THE PATIENT WAS ASYMPTOMATIC FOLLO

  Patient problems: Fistula; Rupture

  MAUDE report 9345017 ↗