RapidCross™ A14BX020120170Recalls & reported problems
Covidien LP · PTA A14BX020120170 RAPIDCROSS V03 · 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 00821684067284), received between Jan 20, 2022 and Jan 20, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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
- Burst Container or Vessel1
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.
MalfunctionJan 20, 2022Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN WAS ATTEMPTING TO USE THE RAPIDCROSS PTA BALLOON DURING PROCEDURE TO TREAT MODERATELY CALCIFIED LESION IN THE DISTAL LEFT ANTERIOR TIBIAL ARTERY. THE VESSEL HAD LITTLE TORTUOSITY. A NON MEDTRONIC INFLATION DEVICE WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THERE WAS A LONGITUDINAL BALLOON BURST AT 4 ATM DURING BALLOON INFLATION. NO FRAGMENTS WERE LEFT BEHIND. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13304436 ↗
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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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