Broadway 8 BRW084132-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327624106), received between Feb 24, 2025 and Mar 10, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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

• MalfunctionMar 10, 2026Fracture

  IT WAS REPORTED THAT WHEN THE PHYSICIAN TRIED TO PUT THE STENT THROUGH THE SUBJECT CATHETER, THE DISTAL TIP OF THE SUBJECT CATHETER WAS FRACTURED. THE SUBJECT CATHETER WAS REMOVED, AND PHYSICIAN CONTINUED THE PROCEDURE WITH THE INTERMEDIATE CATHETER USED DURING THE PROCEDURE. 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 24562452 ↗
• MalfunctionMar 9, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE CATHETER (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, THE PHYSICIAN NOTED THAT THE CLOT COULD NOT BE PULLED, ON INSPECTION THE PROXIMAL OF THE SUBJECT CATHETER WAS NOTED TO BE KINKED. THE PHYSICIAN BELIEVED THAT AIR WAS BEING PULLED OUT THROUGH AN OPENING IN THE KINK. THUS, THE SUBJECT DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24553657 ↗
• MalfunctionMay 19, 2025Fracture; Fracture

  IT WAS REPORTED DURING THE PROCEDURE THE TIP OF THE SUBJECT CATHETER WAS BROKEN OFF AND WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046448 ↗
• MalfunctionApr 1, 2025Fracture; Fracture

  IT WAS REPORTED DURING THE PROCEDURE AFTER THE FIRST PASS, THE PHYSICIAN PUSHED THE SUBJECT CATHETER HARD TO ACCESS THE TREATMENT SITE AND THE DEVICE KINKED. THE PHYSICIAN STATED IT LOOKED VERY TORN AND ALMOST BROKEN OFF. THE PROCEDURE WAS DELAYED FIVE MINUTES AND COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21749124 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BASE CATHETER CLIMBED PAST THE HORIZONTAL PETROUS AND THE SUBJECT CATHETER AND DELIVERY ASSIST CATHETER PARTIALLY CROSSED AND INGESTED THE CLOT IN THE INTERNAL CAROTID ARTERY (ICA). THE CLOT WAS EXTREMELY LARGE AND THE VESSEL WAS DISSECTED PRIOR TO THE PROCEDURE. THE CLOT CREATED A FEW DISTAL EMBOLI WHICH LED TO AN M2 AND TWO M4 OCCLUSIONS. THE M2 OCCLUSION WAS RESOLVED WITH A DIFFERENT CATHETER. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE. UPDATE: FURTHER REVIEW OF COMPLAINT DETAILS ON 04 MARCH 2025: BY PRODUCT ASSESSMENT CENTER MANAGEMENT (PAC), IT IS CLARIFIED THAT THE SUBJECT STENT DISTAL EMBOLI MAY BE A PART OF THE PROCEDURE AND IS NOT DEVICE RELATED. FURTHERMORE, THE EMBOLI IN THE M2 WAS RESOLVED WITH ASPIRATION, AND THE EMBOLI IN M4, IN THE PHYSICIANS OPINION, WOULD RESOLVE ON ITS OWN.

  Patient problems: Embolism/Embolus; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 21445663 ↗