RapidCross™ A14BX025210170 (UDI 00763000110871)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000110871), received between Nov 24, 2021 and Jun 27, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2023Material Fragmentation

  VASCULAR SURGERY PROCEDURE MEDTRONIC RAPID CROSS PTA BALLOON DILATION CATHETER USED DEVICE BROKE APART INSIDE PATIENT ALL PIECES RETRIEVED NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17218728 ↗
• MalfunctionNov 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A RAPID CROSS BALLOON FOR THE TREATMENT OF AN UNKNOWN LESION IN THE MID REGION OF THE ANTERIOR TIBIAL ARTERY. THERE WAS MILD TORTUOSITY AND CALCIFICATION. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU, WITH NO ISSUES IDENTIFIED. THE DEVICE WAS INFLATED USING AN EVEREST INFLATION DEVICE. IT WAS REPORTED AT THE END OF THE PROCEDURE THE BALLOON DETACHED FROM THE CATHETER. DETACHMENT OCCURRED IN VESSEL JUST PROXIMAL TO SHEATH. DETACHED COMPONENT WAS REMOVED. THE PHYSICIAN PULLED THE SHEATH AND USED A CLOSURE DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15867167 ↗
• InjuryDec 16, 2021Material Fragmentation

  SUCCESSFUL ATHERECTOMY AND OPENING OF THE SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY OCCLUSIONS (UNDER GENERAL ANESTHESIA). HOWEVER, A BALLOON CATHETER FRACTURE AND FRAGMENTATION RESULTED IN RETAINED FOREIGN OBJECT THAT COULD NOT BE REMOVED AND NECESSITATED SURGICAL INTERVENTION. MULTIPLE ATTEMPTS TO REMOVE THE FRACTURED AND RETAINED FRAGMENT WERE PERFORMED USING MULTIPLE WIRES AND SNARE CATHETERS. AFTER REVIEW OF IMAGES AND DISCUSSION IT WAS ELECTED THE PATIENT TO BE TAKEN TO THE OPERATING ROOM TO UNDERGO REMOVAL OF THE CATHETER FRAGMENT AS WELL AS REPAIR OF THE COMMON FEMORAL ARTERY STENOSIS AND CONSIDERATION OF POSSIBLE DISTAL BYPASS. ADDED PROCEDURE INCLUDED: REMOVAL OF RETAINED BALLOON CATHETER (FRACTURE) FROM LEFT POPLITEAL ARTERY, LEFT COMMON FEMORAL ENDARTERECTOMY WITH PATCH. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Foreign Body In Patient; Laceration(s)

  MAUDE report 13026044 ↗
• MalfunctionNov 24, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE THE RAPIDCROSS PTA BALLOON DURING PROCEDURE TO TREAT MODERATELY CALCIFIED PLAQUE LESION IN THE MID POSTERIOR TIBIAL ARTERY. THE VESSEL HAD LITTLE TORTUOSITY.  THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE BALLOON WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. IT WAS REPORTED THAT THERE WAS A LONGITUDINAL BALLOON BURST DURING BALLOON INFLATION AT 10 ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT ANY INTERVENTION. THE BALLOON WAS RETRIEVED AND NO FRAGMENTS WERE LEFT BEHIND. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12867655 ↗