RapidCross™ A14BX035150170Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684067789), received between Apr 30, 2019 and Apr 30, 2019 — 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2019Burst Container or Vessel; Expiration Date Error; Burst Container or Vessel; Expiration Date Error

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING A RAPIDCROSS PTA BALLOON TO TREAT A MODERATELY CALCIFIED SEVERELY TORTUOUS 60% STENOTIC LESION IN THE MID DISTAL RIGHT POSTERIOR TIBIAL ARTERY. THE ARTERY DIAMETER AND LESION LENGTH WERE REPORTED TO BE 3MM 100MM, RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY/HOOP. THE DEVICE WAS PREPPED WITHOUT ISSUE. A 6FR NON-MEDTRONIC SHEATH WAS USED WITH NO EMBOLIC PROTECTION. THE DEVICE WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE AND CONTRAST WITH SALINE SOLUTION WAS USED AS INFLATION FLUID. THE BALLOON BURST AT 6ATM. IT WAS REPORTED THAT THERE WERE DIFFICULTIES EXPERIENCED WHEN REMOVING THE DEVICE AS RESISTANCE WAS FELT. THE BALLOON WOULD NOT COME OFF THE GUIDEWIRE THUS, BOTH WERE REMOVED TOGETHER ALONG WITH THE SHEATH. ALL BALLOON FRAGMENTS WERE RETRIEVED. THE BALLOON WAS NOTED TO HAVE BEEN USED PAST ITS UBD. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8565785 ↗