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RunWay™ H74938969020Recalls & reported problems

Boston Scientific Corporation · Guide Catheter · Class 2

All models of RunWay (18)

Data updated Oct 16, 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 08714729477631), received between Nov 6, 2020 and Nov 6, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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 16, 2026.

Most reported problems

Device problems

  • Material Integrity Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionNov 6, 2020Material Integrity Problem; Material Integrity Problem

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15OCT2020. IT WAS REPORTED THAT TIP DAMAGE WAS OBSERVED. A MODEL-6F RUNWAY FR4 CATHETER-GUIDE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER HAS TIP KNEADED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE SOFT PORTION OF THE TIP WAS FRAYED WITH THE BRAIDING EXPOSED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10801365 ↗

Other CATHETER, PERCUTANEOUS devices

All CATHETER, PERCUTANEOUS devices →

Sources and updates

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