RapidCross™ A14BX030080090Recalls & reported problems
Covidien LP · PTA A14BX030080090 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000110949), received between Apr 4, 2024 and Apr 4, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Setup or Prepare1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2024Leak/Splash; Device Difficult to Setup or Prepare; Leak/Splash; Device Difficult to Setup or Prepare
A PHYSICIAN WAS USING A RAPID CROSS PTA BALLOON. IT WAS REPORTED THAT THE 0.014 INCH GUIDEWIRE DOES NOT EXIT THROUGH THE CATHETER GUIDEWIRE PORT LATERALLY, BUT EXITS AT THE PORT CONNECTED TO THE INFLATION LUMEN DISTALLY. WHEN ADMINISTERING SALINE THROUGH THE DISTAL INFLATION PORT, THE OPERATOR NOTICED A LEAK OF SALINE THROUGH THE LATERAL CATHETER GUIDEWIRE PORT. THE OPERATOR DECIDED TO USE ANOTHER BALLOON OF THE SAME REFERENCE (B)(4) TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT. NO DEFORMATION WAS NOTED ON DEVICE. DEVICE WAS USED TO TREAT TIGHT STENOSIS OF THE DISTAL SUPERFICIAL FEMORAL ARTERY. WHEN THE DEVICE WAS RETURNED FOR EVALUATION IT WAS NOTED THAT THERE WAS A LEAK FROM THE TIP OF THE DEVICE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19039718 ↗
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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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