Vaccess® VA5084Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741059728), received between Mar 29, 2019 and Apr 15, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2019Retraction Problem; Retraction Problem

  THIS REPORT SUMMARIZES FOUR MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL VA5084 PTA BALLOON DILATATION CATHETER EXPERIENCED RETRACTION PROBLEMS. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. OF THE FOUR EVENTS, ALL INVOLVED PATIENTS WITH NO CONSEQUENCE OR IMPACT. NONE OF THE PATIENTS¿ WEIGHTS WERE PROVIDED. ONE PATIENT WAS 59 YEARS OLD WITH THE REST DID NOT PROVIDE THEIR AGE. OF THE REPORTED PATIENTS, ONE WAS MALE AND REST WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515087 ↗
• MalfunctionApr 12, 2019Break; Material Rupture; Break; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL VA5084 PTA BALLOON DILATATION CATHETER ALLEGEDLY RUPTURED AND HAD A BREAK. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE DEVICE WAS USED IN THE FORTY-THREE YEAR-OLD MALE PATIENT, OF 150 LBS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8509878 ↗
• InjuryMar 29, 2019Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ANGIOPLASTY OF A VENOUS OUTFLOW, THE PTA BALLOON ALLEGEDLY HAD DIFFICULTY BEING RETRACTED THROUGH THE 6FR SHEATH. IT WAS FURTHER REPORTED THAT UPON RETRACTION THROUGH THE SHEATH, IT WAS IDENTIFIED THAT A SEGMENT OF THE BALLOON DETACHED AND REMAINED IN THE PATIENT. THE HEALTH CARE PROVIDER (HCP) PERFORMED A CUTDOWN TO REMOVE THE DETACHED BALLOON SEGMENT. GUIDED FLUOROSCOPY DEMONSTRATED THAT THE TIP OF THE BALLOON WAS MISSING AND WAS LOCATED IN THE PATIENTS ARM AND THEN MIGRATED TO THE PULMONARY ARTERY. REPORTEDLY, THE HCP DECIDED TO CONCLUDE TREATMENT AND SCHEDULE A RETRIEVAL PROCEDURE FOLLOWING THE DATE OF EVENT. THE PATIENT WAS REPORTED AS ASYMPTOMATIC POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8464617 ↗