RapidCross™ A14BX020060170Recalls & reported problems
Covidien LP · PTA A14BX020060170 RAPIDCROSS V04 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000110611), received between Feb 3, 2022 and Feb 3, 2022 — 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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
PHYSICIAN WAS ATTEMPTING TO USE THE RAPIDCROSS PTA BALLOON DURING PROCEDURE. IT WAS REPORTED THAT WHILE PERFORMING AN INTERVENTION ON AN ARTERIAL LOWER EXTREMITY CHRONIC TOTAL OCCLUSION,AN ANGIOPLASTY BALLOON WAS INFLATED WITHIN THE LESION. AT SOME POINT THEREAFTER THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE BALLOON AND IT BECAME DETACHED FROM THE SHAFT (CATHETER) WITHIN THE ARTERY. DEVICE REMAINS IN PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 13440618 ↗
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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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