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Ultraverse® 014 U4150510Recalls & reported problems

Bard Peripheral Vascular, Inc. · Ultraverse® 014 PTA Balloon Dilatation Catheter 5 mm x 100 mm, 150 cm Catheter · Class 2

All models of Ultraverse 014 (36)

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

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741054167), received between Feb 5, 2018 and Apr 4, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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

Device problems

  • Detachment of Device or Device Component3
  • Break2
  • Device-Device Incompatibility2
  • Device Markings/Labelling Problem1
  • Difficult to Remove1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 4, 2022Break; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Break; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT LOWER EXTREMITY, THE PTA BALLOON WAS ALLEGEDLY STUCK TO THE WIRE AND COULD NOT PULL BACK. IT WAS FURTHER REPORTED THAT BALLOON AND WIRE WERE REMOVED TOGETHER. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13995199 ↗
  • MalfunctionMar 31, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY, THE PTA BALLOON ALLEGEDLY DETACHED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11593981 ↗
  • MalfunctionJan 15, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150510 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A DEVICE MARKINGS ISSUE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION DID NOT INVOLVE A PATIENT, THUS, NO PATIENT INFORMATION WAS PROVIDED.

    Patient problems: No Patient Involvement

    MAUDE report 9592300 ↗
  • MalfunctionFeb 5, 2018Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

    IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE IN THE DISTAL SFA, THE PTA BALLOON ALLEGEDLY GOT STUCK ON THE GUIDEWIRE AND COULD NOT GO ANY FURTHER. THE GUIDEWIRE AND CATHETER WERE REMOVED FROM THE PATIENT WITHOUT ANY ISSUE. ANOTHER BALLOON AND GUIDEWIRE WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7242396 ↗

Other Catheter, angioplasty, peripheral, transluminal devices

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Sources and updates

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