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RunWay™ H74938969710Recalls & 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 08714729478966), received between Apr 23, 2019 and Apr 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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

  • Tear, Rip or Hole in Device Packaging1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionApr 23, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    IT WAS REPORTED THAT A HOLE IN THE PACKAGE OCCURRED. A MODEL-6F RUNWAY WAS SELECTED FOR USE. DURING PREPARATION, WHEN THE DEVICE WAS REMOVED FROM THE BOX, IT WAS NOTED THAT THERE WAS A PUNCTURE HOLE IN THE CATHETER PACKAGING. NO PATIENT INVOLVEMENT WERE REPORTED.

    Patient problems: No Patient Involvement

    MAUDE report 8541434 ↗

Other CATHETER, PERCUTANEOUS devices

All CATHETER, PERCUTANEOUS devices →

Sources and updates

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