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RunWay™ H74938969070Recalls & reported problems

Boston Scientific Corporation · Guide Catheter · Class 2

All models of RunWay (18)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729477686), received between May 16, 2022 and May 16, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Device problems

  • Detachment of Device or Device Component1
  • Material Deformation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 16, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

    IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. THE PATIENT PRESENTED FOR LEFT CORONARY CATHETERIZATION. A RUNWAY GUIDE CATHETER WAS SELECTED FOR USE BUT DURING THE PROCEDURE, THERE WAS A CATHETER FRACTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14408175 ↗

Other CATHETER, PERCUTANEOUS devices

All CATHETER, PERCUTANEOUS devices →

Sources and updates

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