RunWay™ H749389695750Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729478393), received between Sep 11, 2020 and Sep 11, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Deformation1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2020Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT THE CATHETER BROKE, REQUIRING SURGERY FOR REMOVAL. THE TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY. A 6F RUNWAY CLS4 GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CARDIAC CATHETER BROKE OFF WHILE IN THE PATIENT. THE HUB OF THE CATHETER BROKE AND THE CATHETER HAD SIGNIFICANT KINKS. PATIENT WAS TRANSFERRED TO HOSPITAL WITH VASCULAR SURGERY CAPABILITIES SINCE CATHETER WAS UNABLE TO BE RETRIEVED IN CARDIOVASCULAR LAB. FEMORAL ARTERY WAS CUTDOWN AND CATHETER RETRIEVAL WAS COMPLETED WITHOUT FURTHER INCIDENT.
Patient problems: No Code Available
MAUDE report 10521226 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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