Vaccess® VA8064Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741121296), received between Aug 15, 2018 and Apr 23, 2025 — classified as 1 injury, 5 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DESKINNED WHEN IT WAS BEING PULLED OUT. IT WAS FURTHER REPORTED THAT PART GOT STUCK IN THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887918 ↗
• MalfunctionMar 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DISTAL TIP OF THE PTA BALLOON ALLEGEDLY CAME OFF. IT WAS FURTHER REPORTED THAT THE TIP AS SNARED OUT SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21628408 ↗
• InjuryFeb 27, 2025Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE TIP OF THE PTA BALLOON WAS ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT AFTER SEVERAL ATTEMPTS TO SNARE THE TIP OF THE FRACTURED PTA BALLOON, A STENT WAS DEPLOYED TO SMASH THE REMAINS OF PTA BALLOON. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21475937 ↗
• MalfunctionMar 4, 2023Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS INFLATED AND THE PTA BALLOON CATHETER ALLEGEDLY HAD SMALL HOLE AT THE PROXIMAL PORTION OF THE SHAFT WHERE THE DILUTED CONTRAST 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 16483362 ↗
• MalfunctionOct 30, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VA8064 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A RUPTURE. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE FEMALE PATIENT IS 62 YEARS OLD AND WEIGHS 51 KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10760161 ↗
• MalfunctionAug 15, 2018Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY WAS NOT ABLE TO BE RETRACTED THROUGH THE SHEATH. REPORTEDLY, A 7FR SHEATH WAS USED TO PULL THE BALLOON AND ORIGINAL SHEATH TOGETHER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7787179 ↗