RapidCross™ A14BX030150170Recalls & reported problems
Covidien LP · PTA A14BX030150170 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 00763000111014), received between Dec 16, 2022 and Dec 16, 2022 — 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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
A PHYSICIAN WAS USING A RAPID CROSS PTA BALLOONS FOR THE TREATMENT OF A 300MM CALCIFIED LESION IN THE MID/DISTAL REGION OF THE SUPERFICIAL FEMORAL ARTERY <(>&<)> POPLITEAL ARTERY. THE DEGREE OF TORTUOSITY WAS MILD AND THERE WAS MODERATE CALCIFICATION. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. A 6FR NO-MDT SHEATH AND 0.014" NITREX GUIDEWIRE WERE USED. THE BALLOON WAS INFLATED USING A NON-MDT INFLATION DEVICE AND 50 SALINE/50 CONTRAST INFLATION FLUID. THE DEVICES WERE PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED BOTH THE BALLOONS DETACHED IN VIVO AND PORTION OF THE DEVICE WHICH REMAINED IN THE PATIENT COULD NOT BE SNARED OR REMOVED AND THE BALLOONS WERE STENTED IN PLACE. A NON MEDTRONIC SNARE WAS USED.
Patient problems: Insufficient Information
MAUDE report 15994526 ↗
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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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