Trevo XP ProVue 93068Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815742000689), received between Aug 14, 2019 and Mar 22, 2021 — classified as 2 deaths, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 23, 2024Class IIOpen, Classified

   Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

   Z-1902-2024 · Root cause: Process design · Recall details · FDA record ↗

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.

• DeathMar 22, 2021Fracture; Difficult to Remove; Fracture; Difficult to Remove

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE IN THE LEFT M1 VESSEL, THE COMBINATION ASPIRATION AND STENT RETRIEVER TECHNIQUE WAS USED. DURING THE FIRST PASS, AFTER APPLYING SIGNIFICANT FORCE TO THE PROXIMAL END OF THE STENT RETRIEVER WHILE ATTEMPTING TO REMOVE THE CLOT, THE STENT RETRIEVER FRACTURED AT THE JUNCTION ZONE. A SNARE DEVICE WAS USED TO TRY AND RECOVER THE FRACTURED STENT RETRIEVER BUT WAS UNSUCCESSFUL EVEN AFTER SEVERAL ATTEMPTS. THE PHYSICIAN THEN ATTEMPTED TO USE THE SECOND SUBJECT STENT RETRIEVER TO TRY AND REMOVE THE FIRST STENT RETRIEVER THAT HAD FRACTURED. DURING THE FIRST PASS WITH THE SECOND SUBJECT STENT RETRIEVER, IT FRACTURED. THE PHYSICIAN TRIED TO SNARE THE SECOND SUBJECT STENT RETRIEVER BUT WAS UNSUCCESSFUL AND LEFT BOTH FRAGMENTS INSIDE THE PATIENT ANATOMY. THERE WAS REPORTED SURGICAL DELAY BUT EXACT DURATION IS UNKNOWN. NO OTHER INTERVENTION WAS DONE IN RESPONSE TO THIS EVENT. PATIENT CONDITION IMMEDIATELY POST PROCEDURE WAS UNKNOWN. PATIENT WAS REPORTED TO HAVE PASSED AWAY AT AN UNKNOWN DATE. RELATIONSHIP OF PATIENT DEATH TO STENT RETRIEVERS AND ASSOCIATED PROCEDURE IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11545988 ↗
• DeathMar 22, 2021Fracture; Difficult to Remove; Fracture; Difficult to Remove

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE IN THE LEFT M1 VESSEL, THE COMBINATION ASPIRATION AND STENT RETRIEVER TECHNIQUE WAS USED. DURING THE FIRST PASS, AFTER APPLYING SIGNIFICANT FORCE TO THE PROXIMAL END OF THE SUBJECT STENT RETRIEVER WHILE ATTEMPTING TO REMOVE THE CLOT, THE SUBJECT STENT RETRIEVER FRACTURED AT THE JUNCTION ZONE. A SNARE DEVICE WAS USED TO TRY AND RECOVER THE FRACTURED SUBJECT STENT RETRIEVER BUT WAS UNSUCCESSFUL EVEN AFTER SEVERAL ATTEMPTS. THE PHYSICIAN THEN ATTEMPTED TO USE A SECOND STENT RETRIEVER TO TRY AND REMOVE THE FIRST SUBJECT STENT RETRIEVER THAT HAD FRACTURED. DURING THE FIRST PASS WITH THE SECOND STENT RETRIEVER, IT FRACTURED. THE PHYSICIAN TRIED TO SNARE THE SECOND STENT RETRIEVER BUT WAS UNSUCCESSFUL AND LEFT BOTH FRAGMENTS INSIDE THE PATIENT ANATOMY. THERE WAS REPORTED SURGICAL DELAY BUT EXACT DURATION IS UNKNOWN. NO OTHER INTERVENTION WAS DONE IN RESPONSE TO THIS EVENT. PATIENT CONDITION IMMEDIATELY POST PROCEDURE WAS UNKNOWN. PATIENT WAS REPORTED TO HAVE PASSED AWAY AT AN UNKNOWN DATE. RELATIONSHIP OF PATIENT DEATH TO STENT RETRIEVERS AND ASSOCIATED PROCEDURE IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11545573 ↗
• MalfunctionAug 14, 2019Break; Break

  IT WAS REPORTED THAT AFTER THE SECOND PASS WITH THE SUBJECT DEVICE DURING THE THROMBECTOMY PROCEDURE, SOME ¿WIRE LIKE¿ METALLIC MATERIAL WAS NOTED SEPARATING FROM THE DEVICE. THEREFORE, THE PHYSICIAN ELECTED TO STOP THE PROCEDURE WITH M1 OCCLUSION NOT OPEN, AS OTHER DEVICES WERE USED PRIOR TO THE ATTEMPTS WITH THE SUBJECT DEVICE BUT WAS UNABLE TO REMOVE THE CLOT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8893999 ↗