Trevo Trak 21 90338Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327313956), received between Sep 10, 2020 and Jul 9, 2025 — classified as 1 death, 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (3 reports).

4 FDA recall records name this device's identifier, 4 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. Aug 30, 2024Class IIOpen, Classified

   Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US.

   Z-0021-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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-1906-2024 · Root cause: Process design · Recall details · FDA record ↗

3. Dec 6, 2023Class IIOpen, Classified

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

   Z-1085-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Jun 3, 2022Class IIOpen, Classified

   Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.

   Z-1386-2022 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE SUBJECT CATHETER WAS REMOVED FROM THE PATIENT, IT WAS FOUND BROKEN. THE SUBJECT DEVICE 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 22459388 ↗
• MalfunctionApr 30, 2025Peeled/Delaminated; Peeled/Delaminated

  THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT CATHETER PTFE INNER LINING WAS PEELED. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937243 ↗
• MalfunctionMar 21, 2023Material Puncture/Hole; Material Puncture/Hole

  ANALYSIS OF THE DEVICE REVEALED THAT THE MICROCATHETER (SUBJECT DEVICE) HAD A HOLE IN THE SHAFT; THEREFORE, BASED ON THIS INFORMATION THE EVENT IS DEEMED REPORTABLE AND MDR WILL BE FILED WITH AN AWARENESS DATE OF 14-FEB-2023. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16588075 ↗
• MalfunctionJan 31, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT AFTER SUCCESSFUL COMPLETION OF THE PROCEDURE WHEN THE SUBJECT CATHETER WAS STORED IN A TRAY, SOMETHING LIKE COATING SUBSTANCE WAS FOUND FLOATING IN THE SALINE SOLUTION IN THE TRAY. IT IS UNCLEAR AT WHAT POINT IN TIME THIS OCCURRED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270014 ↗
• MalfunctionDec 21, 2022Material Puncture/Hole; Material Puncture/Hole

  THE CATHETER (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE CATHETER (SUBJECT DEVICE) SHAFT HAS A HOLE/PERFORATION. 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 16030165 ↗
• DeathNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  57 ENDOVASCULAR NEUROSURGEONS, 78 INTERVENTIONAL CARDIOLOGISTS, 6 INTERVENTIONAL NEUROLOGISTS, 9 INTERVENTIONAL NEURORADIOLOGISTS, AND 36 INTERVENTIONAL RADIOLOGISTS PARTICIPATED IN THE POST-MARKET CLINICAL FOLLOW-UP (PMCF) ANONYMOUS SURVEY FOR SUBJECT TREVO TRAK 21 MICROCATHETER. THE SURVEY WAS CONDUCTED IN AUSTRALIA, FRANCE, GERMANY, ITALY, JAPAN, SPAIN, UNITED KINGDOM AND UNITED STATES. DURING THE SURVEY MORTALITY WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE ABOUT THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 12839011 ↗
• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  57 ENDOVASCULAR NEUROSURGEONS, 78 INTERVENTIONAL CARDIOLOGISTS, 6 INTERVENTIONAL NEUROLOGISTS, 9 INTERVENTIONAL NEURORADIOLOGISTS, AND 36 INTERVENTIONAL RADIOLOGISTS PARTICIPATED IN THE POST-MARKET CLINICAL FOLLOW-UP (PMCF) ANONYMOUS SURVEY FOR SUBJECT TREVO TRAK 21 MICROCATHETER. THE SURVEY WAS CONDUCTED IN AUSTRALIA, FRANCE, GERMANY, ITALY, JAPAN, SPAIN, UNITED KINGDOM AND UNITED STATES. DURING THE SURVEY HEMORRHAGIC COMPLICATION, RE-OCCLUSION, VESSEL DISSECTION, CLOT EMBOLIZATION, NEUROLOGICAL DEFICITS, ANEURYSM RECURRENCE, VESSEL PERFORATION, STROKE/TIA, VASOSPASM, AND GROIN HEMATOMA WERE REPORTED. NO OTHER INFORMATION IS AVAILABLE ABOUT THIS EVENT.

  Patient problems: Hematoma; Obstruction/Occlusion; Perforation of Vessels; Rupture; Stroke/CVA; Thromboembolism; Vascular Dissection; Vasoconstriction

  MAUDE report 12838143 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE THROMBUS RECOVERY PROCEDURE FOR MCA LESIONS, THE PHYSICIAN USED AN ACCESS CATHETER AND SUBJECT MICROCATHETER TO SUCCESSFULLY DELIVER A STENT RETRIEVER. HOWEVER, THE BLOOD CLOTS REMAINED, THE PHYSICIAN USED A REPERFUSION CATHETER IN COMBINATION WITH A MICROCATHETER TO ACCESS THE TREATING SITE BUT COULD NOT CROSS THE REGION. THEREFORE, BOTH DEVICES WERE WITHDRAWN. THE PHYSICIAN THEN REATTEMPTED TO APPROACH THE ANEURYSM BY COMBINING THE SUBJECT CATHETER WITH ANOTHER CATHETER BUT WAS UNSUCCESSFUL. THE PHYSICIAN GAVE UP TREATMENT AND IT WAS REPORTED THAT THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THE SUBJECT CATHETER FRAGMENTS WERE NOTED IN THE PERIPHERAL AREA IN THE POSTOPERATIVE CT IMAGING. THE LOCATION OF CATHETER FRAGMENTS ARE UNKNOWN FOR THE SPECIFIC POSITION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12332370 ↗
• MalfunctionFeb 24, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE DURING THE PROCEDURE, THE SUBJECT CATHETER WAS USED TO APPROACH THE LESION SITE. A RETRIEVER WAS THEN ATTEMPTED TO APPROACH AFTERWARD BUT WAS STUCK AT THE HUB OF THE SUBJECT CATHETER. PHYSICIAN THEN PROCEEDED TO REMOVE THE STUCK RETRIEVER AND REPLACED IT WITH A SIMILAR PRODUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO CLINICAL CONSEQUENCES WAS NOTED TO THE PATIENT. ANALYSIS OF THE RETURNED SUBJECT CATHETER REVEALED THAT THE PTFE INNER LINING PEELING AT THE PROXIMAL END OF THE SUBJECT CATHETER SHAFT WAS PEELING. THEREFORE, BASED ON THIS INFORMATION THE EVENT IS DEEMED REPORTABLE WITH AN AWARENESS DATE OF (B)(6) 2021. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376313 ↗
• MalfunctionSep 10, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT DURING THE PROCEDURE FOR M1 OCCLUSION, SUBJECT MICROCATHETER WAS USED TO FACILITATE RETRIEVER TO TARGET OCCLUSION. PHYSICIAN HAD SUCCESSFUL FIRST PASS USING SUBJECT MICROCATHETER AND RETRIEVER. UPON SECOND PASS, PHYSICIAN NOTED THAT DISTAL R/O MARKER FOR THE SUBJECT CATHETER WAS NOT VISIBLE. THE DISTAL MARKER WAS NO PRESENT UPON PHYSICIAN INSPECTION AND WAS CONFIRMED UNDER FLUOROSCOPY THAT THE MARKER WAS NOT WITHIN PATIENT BODY. THE PHYSICIAN CONTINUED THE PROCEDURE AND PATIENT HAD FULL REVASCULARIZATION AS THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 10519051 ↗