Skip to content

RapidCross™ A14BX040150170 (UDI 00763000111335)Recalls & reported problems

Covidien LP · PTA A14BX040150170 RAPIDCROSS V04 · Class 2

All models of RapidCross (26)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000111335), received between Dec 21, 2020 and Dec 21, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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

Device problems

  • Burst Container or Vessel1
  • Device Damaged by Another Device1
  • Difficult to Remove1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 21, 2020Burst Container or Vessel; Difficult to Remove; Device Damaged by Another Device; Burst Container or Vessel; Difficult to Remove; Device Damaged by Another Device

    PHYSICIAN INTENDED TO USE A RAPIDCROSS PTA BALLOON WITH A NON-MEDTRONIC 6FR SHEATH AND 0.014 NON-MEDTRONIC WIRE DURING TREATMENT OF A 150MM CTO (CHRONIC TOTAL OCCLUSION - 100%) IN THE PATIENT¿S DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL CALCIFICATION IS REPORTED. ARTERY DIAMETER REPORTED AS 6MM. A NON-MEDTRONIC (BARD) INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED ONCE THE SFA CTO WAS CROSSED AND CONFIRMED, THE 0.014 NON-MEDTRONIC WIRE WAS PLACED, AND THE RAPIDCROSS BALLOON WAS ADVANCED INTO THE DISTAL SFA AT THE RE-ENTRY AREA. THE BALLOON WAS INFLATED 3 TIMES IN THE SFA AND ON THE 4TH TIME A LONGITUDINAL BURST AT 14ATM IS REPORTED. WHEN THE PHYSICIAN WAS REMOVING BALLOON, RESISTANCE WAS FELT COMING INTO THE SHEATH. THE PHYSICIAN GENTLY TUGGED ON THE CATHETER, BUT IT WOULD NOT MOVE. THE PHYSICIAN THEN TUGGED ON THE WIRE AND FOND THE WIRE WAS STUCK ONTO THE BALLOON AND THE SHEATH. THE PHYSICIAN THEN USED A BUDDY WIRE AND HAD TO REMOVE THE WHOLE SHEATH DUE TO THE BALLO

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11045308 ↗

Other Catheter, angioplasty, peripheral, transluminal devices

All Catheter, angioplasty, peripheral, transluminal devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page