RapidCross™ A14BX025210170 (UDI 00821684067482)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684067482), received between Jun 14, 2019 and Aug 18, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2020Fracture; Difficult to Remove; Detachment of Device or Device Component; Fracture; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A RAPIDCROSS PTA BALLOON ALONG WITH NON-MEDTRONIC 7FR SHEATH, GUIDE WIRE AND EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE IN THE PROXIMAL, MID AND DISTAL POSTERIOR TIBIAL ARTERY (PTA) WITH 80% STENOSIS. THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 2.5MM AND 100MM RESPECTIVELY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT WHILE REMOVING THE BALLOON AFTER INFLATION, BREAK/FRACTURE OCCURRED AT THE LUER/HUB. IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED, THERE WAS DIFFICULTY REMOVING BALLOON FOLLOWING BALLOON INFLATION AND A NON-MEDTRONIC SNARE DEVICE WAS USED TO REMOVE DETACHED BALLOON. AFTER BALLOON WAS REMOVED PHYSICIAN STUNTED THE ILIAC AND FINISHED THE PROCEDURE. THERE WAS NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Injury

  MAUDE report 10418809 ↗
• MalfunctionNov 15, 2019Fracture; Difficult to Advance; Fracture; Difficult to Advance

  PHYSICIAN INTENDED TO USE A RAPIDCROSS PTA BALLOON WITH A NON-MEDTRONIC 6FR SHEATH AND A 0.014 NON-MEDTRONIC GUIDE CATHETER DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S MID ANTERIOR TIBIAL ARTERY. LESION EXHIBITED 80% STENOSIS. MODERATE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM PACKAGING. IFU WAS FOLLOWED. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT IS REPORTED THAT A BREAK/FRACTURE OCCURRED ON THE DISTAL HALF OF THE BALLOON CATHETER. IT IS UNCLEAR WHEN THE FRACTURE OCCURRED. THERE WERE NO DETACHED COMPONENTS. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE OVER THE WIRE. A NEW RAPIDCROSS BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9325874 ↗
• MalfunctionJun 14, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A RAPIDCROSS PTA BALLOON TO TREAT A SEVERELY CALCIFIED, MODERATELY TORTUOUS CHRONIC TOTAL OCCLUSION (100%, CTO) LESION IN THE MID TIBIAL/POPLITEAL ARTERY. 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. NO EMBOLIC PROTECTION WAS USED. THE DEVICE WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, HOWEVER, RESISTANCE WAS ENCOUNTERED BUT NO EXCESSIVE FORCE USED ON ADVANCING THE DEVICE TO THE TARGET LESION. DURING BALLOON INFLATION TO 8ATM, THE BALLOON IS REPORTED TO HAVE BURST DUE TO A PIN HOLE LEAK. THE DEVICE WAS REMOVED AND THE PROCEDURE WILL BE COMPLETED ON ANOTHER DAY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8699322 ↗