Trevo 90238Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00815742002386), received between Feb 19, 2019 and Aug 14, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

4 other recalls cover devices cleared under the same FDA submission (K113260); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 23, 2024Open, 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-1904-2024 · Root cause: Process design · FDA record ↗

2. Dec 6, 2023Open, Classified

   The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

   Z-1084-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2024Peeled/Delaminated; Peeled/Delaminated

  DURING RIGHT INTERNAL CAROTID ARTERY (ICA) THROMBECTOMY PROCEDURE, THE OPERATOR FLUSHED AND DELIVERED A GUIDEWIRE INTO A SUBJECT MICROCATHETER AND DELIVERED THEM TO THE TARGET LESION. AFTER THE SUBJECT MICROCATHETER REACHED MCA M1, THE OPERATOR DEPLOYED A RETRIEVER AND ASPIRATED WITH A DISTAL ACCESS CATHETER AT SIPHON SECTION. NEXT, THE OPERATOR WITHDREW THE RETRIEVER AND THE SUBJECT MICROCATHETER BACK INTO THE DISTAL ACCESS CATHETER AND CHECKED ICA C7 UNDER THE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). THE ANGIOGRAPHY REVEALED THAT THE C7 WAS NOT OPENED. THE OPERATOR PREPARED TO PERFORM THE SECOND THROMBECTOMY. WHEN THE OPERATOR DELIVERED THE GUIDEWIRE INTO THE SUBJECT MICROCATHETER, HE FELT FRICTION AND RESISTANCE. WHEN THE OPERATOR REACHED M1, HE DELIVERED THE RETRIEVER AND IT ALSO ENCOUNTERED RESISTANCE INSIDE THE SUBJECT MICROCATHETER. THUS, THE OPERATOR WITHDREW THE RETRIEVER AND THE DISTAL ACCESS CATHETER AND REPLACED THE SUBJECT MICROCATHETER. THE OPERATOR CONCLUDED THAT THE COATING OF THE SUBJECT MICROCATHETER PEELED OFF WHICH CAUSED THE RESISTANCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986746 ↗
• MalfunctionMar 26, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE WHEN THE OPERATOR ATTEMPTED TO DELIVER THE RETRIEVER STENT THROUGH THE SUBJECT MICROCATHETER, THE STENT RETRIEVER COULD NOT BE ADVANCED PAST MIDDLE CEREBRAL ARTERY (MCA) C5 SEGMENT. THE OPERATOR WITHDREW THE SUBJECT MICROCATHETER AND THE STENT OUT TOGETHER TO CHECK AND FOUND THAT THE INNER WALL PTFE LINER OF THE SUBJECT MICROCATHETER WAS PEELED. THE SUBJECT MICROCATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18984012 ↗
• MalfunctionNov 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACUTE THROMBECTOMY CASE, WHEN THE PHYSICIAN ATTEMPTED TO BUILD ACCESS WITH THE SUPPORT OF A GUIDEWIRE, THE DISTAL OF THE SUBJECT CATHETER KINKED AND EVENTUALLY FRACTURED WHILE BEING DELIVERED INTO THE PATIENT. THE DEVICE WAS REMOVED WITH THE GUIDEWIRE AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15886476 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THROMBECTOMY PROCEDURE, THE SUBJECT DEVICE MICROCATHETER (TREVO PRO MICROCATHETER) AND OTHER DEVICES WERE USED TO REMOVE THE PROXIMAL FACE OF CLOT LOCATED AT THE RIGHT ICA (INTERNAL CAROTID ARTERY)- INTRACRANIAL-T (BIFURCATION) EXTENDING TO M1 AND M2. PRIOR PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE TICI (THROMBOLYSIS IN CEREBRAL INFARCTION SCORE) OF 0. IT WAS REPORTED THAT THE VESSEL PERFORATION OCCURRED DURING MANIPULATION. THERE WERE NO SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH) OR NEUROLOGICAL DETERIORATION REPORTED. THE EVENT WAS RESOLVED WITHOUT MEDICAL TREATMENT TO THE PATIENT. 24 HOURS POST PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED (TICI) OF 3 AND NIHSS OF 18. ACCORDING TO THE SITE, THE RELATIONSHIP OF THE VESSEL PERFORATION TO THE SUBJECT DEVICE MICROCATHETER AND TO THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 11121898 ↗
• MalfunctionFeb 19, 2019Break; Break

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE MICROCATHETER SHAFT WAS BROKEN. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8352625 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113260. One submission often covers many models, so check the product and lot details in each record.

• Z-0347-2018 · Nov 28, 2017 · Terminated
  Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
• Z-0277-2018 · Nov 3, 2017 · Terminated
  Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 Stroke intervention
• Z-0275-2018 · Nov 3, 2017 · Terminated
  Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.0
• Z-0276-2018 · Nov 3, 2017 · Terminated
  Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Acc