RapidCross™ A14BX040150170 (UDI 00821684067949)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684067949), received between Jan 17, 2017 and Jan 25, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 25, 2019Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  THE PHYSICIAN WAS INTENDING TO USE A RAPIDCROSS TO TREAT A SOFT TISSUE LESION IN THE UPPER EXTREMITY. THE DEVICE WAS PREPPED WITH NO ISSUES. NO EMBOLIC PROTECTION WAS USED. DURING INFLATION WITH A BOSTON SCIENTIFIC INFLATION DEVICE, A BALLOON BURST OCCURRED AT NOMINAL ATM. THE BALLOON DETACHED FROM THE SHAFT WHILE RETRIEVING THE DEVICE THROUGH THE SHEATH AND THE BALLOON REMAINED IN THE PATIENT. THE PATIENT HAD SURGERY TO REMOVE THE BALLOON.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8277450 ↗
• InjuryJun 21, 2017Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A RAPIDCROSS WITH A 6FR 90CM DESTINATION SHEATH AND .014 300CM GUIDEWIRE FOR TREATMENT OF A MODERATELY CALCIFIED LESION WITH LITTLE DEGREE OF TORTUOSITY IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. LESION EXHIBITED 40% STENOSIS. PATIENT HAD A BI AORTIC ILIAC BYPASS GRAFT. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ANY ISSUES IDENTIFIED. THE BALLOON BURST FOLLOWING SECOND INFLATION AT AN INFLATION PRESSURE OF 10 ATM¿S. THE PHYSICIAN ATTEMPTED TO SNARE IT (USING A GOOSENECK SNARE) BUT THE DEVICE WASN¿T LONG ENOUGH BECAUSE OF ACCESS IN THE RIGHT BRACHIAL ARTERY. WHEN THE PHYSICIAN TRIED TO REMOVE THE BURST BALLOON THROUGH THE SHEATH, IT GOT CAUGHT ON THE WIRE AND THE SHEATH RESULTING IN THE DISTAL TIP BREAKING OFF. PHYSICIAN ALSO ATTEMPTED TO RETRIEVE IT USING THE BASKET ON A 7MM SPIDER. SURGERY WAS REQUIRED TO RETRIEVE THE TIP OF THE BALLOON WHICH REMAINED IN THE GRAFT WHICH WAS COMPLETED THE NEXT DAY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6659391 ↗
• MalfunctionJan 17, 2017Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO TREAT PATIENT USING A RAPIDCROSS BALLOON AT THE DISTAL SUPERFICIAL FEMORAL ARTERY. LESION TYPE WAS FIBROUS WITH LITTLE TORTUOSITY AND MODERATE CALCIFICATION. ARTERY DIAMETER WAS 4 MM AND LESION LENGTH WAS 150 MM. A 6F SHEATH WAS USED. AN INFLATION DEVICE WAS USED WITH DILUTED CONTRAST FOR INFLATION. IT IS REPORTED THAT BALLOON BURST DURING FIRST INFLATION UNDER NOMINAL PRESSURE. NO ISSUES WERE NOTED PRIOR TO USE. NO RESISTANCE NOTED WHEN ADVANCING THE DEVICE. A SECOND BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6255829 ↗