RapidCross™ A14BX030040170 (UDI 00763000110918)Recalls & reported problems
Covidien LP · PTA A14BX030040170 RAPIDCROSS V04 · Class 2
All models of RapidCross (26)
Data updated Oct 16, 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 00763000110918), received between Oct 3, 2019 and Oct 3, 2019 — 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 16, 2026.
Most reported problems
Device problems
- Break1
- Burst Container or Vessel1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2019Break; Burst Container or Vessel; Break; Burst Container or Vessel
PHYSICIAN INTENDED TO USE A RAPIDCROSS BALLOON WITH A .014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT A LESION IN THE DISTAL ANTERIOR TIBIAL ARTERY. MODERATE TORTUOSITY AND CALCIFICATION ARE REPORTED. IFU WAS FOLLOWED. IT IS REPORTED THAT THE BALLOON BROKE, AND THE PATIENT WAS TRANSFERRED FOR SURGERY TO HAVE THE BROKEN PIECE REMOVED.
Patient problems: Injury
MAUDE report 9151159 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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