RapidCross™ A14BX040040170Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684067840), received between Mar 6, 2019 and Mar 6, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

Recent adverse event reports

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

• MalfunctionMar 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A RAPIDCROSS DILATION BALLOON TO TREAT A LESION IN THE PROX PERONEAL ARTERY WITH SEVERE CALCIFICATION AND 80% STENOSIS IN A PATIENT. A NON-MEDTRONIC (VIPER WIRE) WAS USED. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY, NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY, DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT DEVICE OR COMPONENT DETACHED, CRACKED, OR FRACTURED OCCURRED; THE DEVICE DETACHED AT HUB OF SHEATH UPON REMOVAL. SMALL PORTION WAS HANGING OUT OF THE SHEATH, SO THE PHYSICIAN WAS ABLE TO GRAB AND REMOVE IT. DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8393992 ↗