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Ultraverse® 035 PTA Dilatation Catheter U3575510Recalls & reported problems

Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 5.0mm x 100mm balloon, 75cm shaft · Class 2

All models of Ultraverse 035 PTA Dilatation Catheter (92)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741092480), received between Jan 29, 2018 and Jun 3, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 18, 2026.

Most reported problems

Device problems

  • Material Rupture4
  • Break1
  • Kinked1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient2
  • No Patient Involvement1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 3, 2021Material Rupture; Material Rupture

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A HIGHLY CALCIFIED TARGET LESION IN THE COMMON FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11927526 ↗
  • MalfunctionApr 28, 2021Material Rupture; Material Rupture

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED UNDER NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11736297 ↗
  • MalfunctionJul 22, 2020Material Rupture; Material Rupture

    THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL U3575510 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THE INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. ALL THREE MALFUNCTIONS INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. THE AGE AND WEIGHT OF THE THREE FEMALE PATIENTS WERE NOT PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10309746 ↗
  • MalfunctionApr 15, 2020Material Rupture; Material Rupture

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF REPORTED INFORMATION INDICATES THAT MODEL U3575510, PTA BALLOON DILATATION CATHEER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A MALE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE AND WEIGHT HAVE NOT BEEN PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9964840 ↗
  • MalfunctionJan 29, 2018Break; Kinked; Break; Kinked

    IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE, AN ALLEGED KINK AND BREAK WAS VISIBLE AT THE DISTAL PART OF THE CATHETER SHAFT. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Patient Involvement

    MAUDE report 7226784 ↗

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Sources and updates

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