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Vaccess® VA8076Recalls & reported problems

Bard Peripheral Vascular, Inc. · Vaccess® PTA Dilatation Catheter 7 mm x 60 mm, 80 cm Catheter · Class 2

All models of Vaccess (25)

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

Adverse event reports
4
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741121326), received between Apr 16, 2020 and Apr 13, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Device problems

  • Break4
  • Retraction Problem3
  • Detachment of Device or Device Component2
  • Material Rupture2

Patient problems

  • No Consequences Or Impact To Patient2
  • Injury1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionApr 13, 2022Break; Break

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT ARM, THE PTA BALLOON ALLEGEDLY BROKE WHILE REMOVING THROUGH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14097817 ↗
  • MalfunctionJul 22, 2020Break; Retraction Problem; Detachment of Device or Device Component; Break; Retraction Problem; Detachment of Device or Device Component

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL VA8076 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A RETRACTION PROBLEM AND BALLOON DETACHMENT. THIS REPORT WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE PATIENTS¿ AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10308239 ↗
  • InjuryJun 9, 2020Break; Retraction Problem; Material Rupture; Detachment of Device or Device Component; Break; Retraction Problem; Material Rupture; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE DISTAL OUTFLOW VEIN OF THE FISTULA, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON BECAME STUCK IN THE SHEATH UPON REMOVAL AND EXCESSIVE FORCE WAS USED TO REMOVE THE BALLOON CAUSING THE BALLOON TO DETACH FROM THE CATHETER SHAFT. REPORTEDLY, THE DETACHED SEGMENT WAS REMOVED AND THE VESSEL STRETCHED DUE TO EXCESSIVE FORCE. THE PHYSICIAN SUTURED THE VESSEL AND CONCLUDE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: Injury

    MAUDE report 10132230 ↗
  • MalfunctionApr 16, 2020Break; Retraction Problem; Material Rupture; Break; Retraction Problem; Material Rupture

    THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL VA8076 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND BREAK. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. NO PATIENT INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9969163 ↗

Other Catheter, angioplasty, peripheral, transluminal devices

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Sources and updates

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