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RunWay™ H74938969686B0Recalls & 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 08714729775294), received between Feb 10, 2020 and Feb 10, 2020 — 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 16, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

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.

  • MalfunctionFeb 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DETACHMENT OF THE DISTAL TIP OCCURRED. A 6F RUNWAY CATHETER WAS SELECTED FOR USE TO VIEW THE TARGET LESION. DURING A PERCUTANEOUS CORONARY INTERVENTION, IT WAS NOTED THAT THE DISTAL TIP PEELED AWAY. THIS OCCURRED INSIDE THE PATIENT, THE CATHETER WAS RETRIEVED WITHOUT ANY FRAGMENTS LEFT INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9688209 ↗

Other CATHETER, PERCUTANEOUS devices

All CATHETER, PERCUTANEOUS devices →

Sources and updates

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