RapidCross™ A14BX020080170 (UDI 00763000110635)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000110635), received between Mar 9, 2021 and Jan 30, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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.

• InjuryJan 30, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A RAPID CROSS PTA BALLOON DURING AN ANGIOPLASTY PROCEDURE. IT WAS REPORTED WITH THE USE OF AN 018 WIRE THEY SELECTED THE ANTERIOR TIBIALIS ARTERY AND ADVANCED A QUICK CROSS CATHETER, SURGEON THEN EXCHANGED THE WIRE FOR AN 014 WIRE. WITH THIS WIRE THEY WERE ABLE TO CROSS THE LESION AND ADVANCED THE QUICK CROSS CATHETER. THEY PERFORMED AN ANGIOGRAM WHICH SHOWED THAT THE CATHETER WAS PLACED IN THE DISTAL DORSALIS PEDIS INTO THE METATARSAL BRANCHES INCLUDING THE THIRD TOE. FOR THIS REASON, THE SURGEON OPTED TO TREAT THIS AREA TO IMPROVE THE CIRCULATION TO THE COMPROMISED TOE. THE PATIENT WAS HEPARINIZED APPROPRIATELY ACCORDING TO WEIGHT WITH A GOAL ACT OF 250. SURGEON OPTED TO USE A QUICK EXCHANGE RAPID CROSS RX 2MM X 80MM RAPID EXCHANGE BALLOON, THIS WAS DONE OVER A WHISPER MS 014 WIRE. SURGEON PERFORMED PROLONGED INFLATION. THEN THE BALLOON WAS TAKEN DOWN, AS SURGICAL TEAM WERE WITHDRAWING THE BALLOON, THE SURGEON NOTED THAT THERE WAS MORE RESISTANCE THAN ANTICIPATED AND THEN SLIGHTLY THERE WAS A SNAP AND SURGEON RETRIEVED THE PROXIMAL END OF THE CATHETER BUT NOT THE BALLOON.  THE SURGEON THEN PERFORMED AN ANGIOGRAM AND IT SHOWED THAT THE BALLOON WAS STILL ATTAC

  Patient problems: Insufficient Information

  MAUDE report 16264451 ↗
• MalfunctionMar 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE RAPIDCROSS PTA BALLOON DURING PROCEDURE TO TREAT THE POSTERIOR TIBIAL ARTERY (PTA). IT WAS REPORTED THAT THE DEVICE OR COMPONENT DETACHED, CRACKED OR FRACTURED. THE BALLOON WAS INSERTED AND PHYSICIAN ATTEMPTED TO INFLATE AND DURING INFLATION, BALLOON SPLIT AND COULD NOT BE INFLATED. THE CATHETER SEPARATED DURING INFLATION. THE DEFECTIVE BALLOON WAS REMOVED INTACT AND USED A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441508 ↗