RapidCross™ A14BX020080170 (UDI 00821684067246)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684067246), received between May 24, 2018 and Apr 20, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2020Deflation Problem; Deflation Problem

  PHYSICIAN INTENDED TO USE A RAPIDCROSS PTA BALLOON DURING PATIENT TREATMENT. NO DAMAGE WAS NOTED TO THE PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT IS REPORTED BALLOON DEFLATION DIFFICULTIES WERE NOTED AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9976691 ↗
• MalfunctionMay 24, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A RAPIDCROSS DEVICE TO TREAT A NON-TORTUOUS LESION WITH LITTLE CALCIFICATION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES IDENTIFIED. NO EMBOLIC PROTECTION WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE TO THE LESION. THE DEVICE WAS REPORTED TO HAVE FRACTURED. THE CATHETER WAS REMOVED OVER THE WIRE, ALL COMPONENTS OF THE DEVICE WERE REMOVED FROM THE PATIENT WITHOUT A NEED FOR INTERVENTION. THE PROCEDURE WAS COMPLETED USING A NANOCROSS DEVICE, WITH NO COMPLICATIONS REPORTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7540037 ↗