Vaccess® VA8086Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741121340), received between Jul 22, 2019 and Mar 5, 2026 — classified as 6 malfunctions.

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

• MalfunctionMar 5, 2026Difficult to Remove

  THE PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY STUCK TO THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516311 ↗
• MalfunctionJan 6, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16110426 ↗
• MalfunctionMay 21, 2021Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO INFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861408 ↗
• MalfunctionApr 14, 2020Break; Retraction Problem; Break; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF REPORTED INFORMATION INDICATES THAT MODEL VA8086, PTA BALLOON DILATATION CATHETER, ALLEGEDLY EXPERIENCED A BREAK AND A RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTIONED INVOLVED A (B)(6) YEAR OLD FEMALE PATIENT WITH NO REPORTED CONSEQUENCES. THE PATIENT'S WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9960695 ↗
• MalfunctionJan 14, 2020Retraction Problem; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VA8086, PTA BALLOON DILATATION CATHETER, ALLEGEDLY EXPERIENCED A RETRACTION PROBLEM. THIS INFORMATION WAS RECIEVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOVLED A PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9586746 ↗
• MalfunctionJul 22, 2019Retraction Problem; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VA8086. PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED RETRACTION PROBLEM. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT IS 74 YEARS OF AGE, THE GENDER IS MALE, AND THE WEIGHT IS 155 KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812540 ↗