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Conquest® CQ12064Recalls & reported problems

Bard Peripheral Vascular, Inc. · Conquest® PTA Balloon Dilatation Catheter 6 mm x 40 mm, 120 cm catheter · Class 2

All models of Conquest (32)

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

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741062933), received between Apr 17, 2018 and Jun 7, 2023 — classified as 3 malfunctions.

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
  • Difficult to Remove1
  • Leak/Splash1
  • Material Frayed1
  • Peeled/Delaminated1
  • Unraveled Material1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJun 7, 2023Difficult to Remove; Difficult to Remove

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, PTA BALLOON ALLEGEDLY STUCK IN THE SHEATH UPON REMOVAL. IT WAS FURTHER REPORTED THAT BALLOON WAS ALLEGEDLY UNABLE TO BE REMOVED. REPORTEDLY THE PATIENT WAS PUNCTURED ADDITIONALLY IN ANOTHER SITE AND SURGICAL INTERVENTION WAS PERFORMED TO COMPLETE THE PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

    MAUDE report 17078405 ↗
  • MalfunctionNov 24, 2021Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, ALLEGEDLY THERE WAS A LEAK IN THE SHAFT AND THE CONTRAST CAME OUT FROM THE SHAFT OF THE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12869280 ↗
  • MalfunctionApr 17, 2018Material Frayed; Peeled/Delaminated; Unraveled Material; Material Frayed; Peeled/Delaminated; Unraveled Material

    IT WAS REPORTED THAT AFTER A FISTULAGRAM, THROMBECTOMY, VENOPLASTY AND STENTING, THE HEALTH CARE PROVIDER FOUND SOME BALLOON FIBERS THAT WERE ALLEGEDLY PEELING OFF. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7438097 ↗

Other CATHETER, PERCUTANEOUS devices

All CATHETER, PERCUTANEOUS devices →

Sources and updates

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