RapidCross™ A14BX035060170Recalls & reported problems
Covidien LP · PTA A14BX035060170 RAPIDCROSS V03 · Class 2
All models of RapidCross (26)
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 00821684067703), received between May 23, 2019 and May 23, 2019 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
DURING USE OF A RAPIDCROSS BALLOON IT IS REPORTED THAT THE BALLOON CAME OFF THE WIRE DURING THE PROCEDURE. IT IS REPORTED THE REMNANTS OF THE BALLOON WERE REMOVED FROM THE PATIENT. THE PATIENT WAS BROUGHT BACK LATER FOR STENTING. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.
Patient problems: Patient Problem/Medical Problem
MAUDE report 8635444 ↗
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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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