RapidCross™ A14BX020150170 (UDI 00763000110697)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000110697), received between Apr 14, 2022 and Sep 11, 2024 — classified as 2 injuries, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A RAPIDCROSS PTA BALLOON WAS BEING USED FOR TREATMENT. THE IFU WAS FOLLOWED. IT WAS REPORTED THE BALLOON DETACHED AT THE TARGET LESION. THE DETACHED BALLOON WAS REMOVED WITH A SNARE, THE DEVICE WAS SAFELY REMOVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20191053 ↗
• InjurySep 24, 2022Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  IT WAS REPORTED THAT A RAPIDCROSS PTA 2.0MM X 150MM X 170CM  BALLOON WAS USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 100% STENOSIS IN THE MID POSTERIOR TIBIAL ARTERY. IT WAS REPORTED THAT  A 6 FR COOK NON MEDTRONIC SHEATH AND A 014 CHOICE NON MEDTRONIC GUIDEWIRE WAS USED. EMBOLIC PROTECTION WAS NOT USED. THE BALLOON WAS INFLATED WITH A NON MEDTRONIC INFLATION DEVICE. HALF/HALF CONTRAST /SALINE INFLATION FLUID WAS USED. THE DEVICE WAS PREPPED PER IFU. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE BALLOON BURST AT 8 ATMS ON THE FIRST INFLATION. DISTAL PORTION OF BALLOON REMAINED IN VESSEL UPON RETRIEVING AND GOOSE NECK SNARE WAS UTILIZED TO ATTEMPT RETRIEVAL. DETACHMENT OCCURRED UPON REMOVAL ATTEMPT. THE BREAK/FRACTURE OCCURRED AT THE BALLOON. THE DETACHED PORTION OF THE DEVICE REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED BY PLACING A 4.0 COOK ZILVER STENT IN PERONEAL UP TO TPT TO PREVENT PROXIMAL PORTION OF BALLOON FROM EMBOLIZING/MIGRATING. NO FURTHER PATIENT INJURY.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 15475825 ↗
• MalfunctionApr 14, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  PHYSICIAN WAS ATTEMPTING TO USE A RAPIDCROSS PTA BALLOON DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE MID A NTERIOR TIBIAL ARTERY (ATA). THE VESSEL WAS LITTLE TORTUOUS. NO EMBOLIC PROTECTION WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. BALLOON DEFLATION DIFFICULTIES WAS REPORTED WITH DEVICE NOT ABLE TO DEFLATE AT LESION SITE. THE DEFLATION ISSUE WAS NOTED FOLLOWING THE FIRST INFLATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT PHYSICIAN WAS UNABLE TO DEFLATE BALLOON EVEN PULLING NEGATIVE WITH INFLATION DEVICE AND SYRINGE. PHYSICIAN WAS FORCED TO PULL OUT THE BALLOON WHILE IT WAS STILL INFLATED AT 6ATM. NO VESSEL DAMAGE OCCURRED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14111361 ↗