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Rival® RV13544Recalls & reported problems

Bard Peripheral Vascular, Inc. · Rival® PTA Balloon Dilatation Catheter 4 mm x 4 cm, 135 cm catheter · Class 2

All models of Rival (15)

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 00801741063374), received between Jul 29, 2021 and Jul 29, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (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

  • Inflation Problem1
  • Leak/Splash1
  • Material Rupture1

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.

  • MalfunctionJul 29, 2021Inflation Problem; Leak/Splash; Material Rupture; Inflation Problem; Leak/Splash; Material Rupture

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD AN INFLATION ISSUE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12243855 ↗

Other CATHETER, PERCUTANEOUS devices

All CATHETER, PERCUTANEOUS devices →

Sources and updates

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