Vaccess® VA8078Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741059933), received between Feb 26, 2018 and Jul 29, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS PTA BALLOON CATHETER FOR THROMBECTOMY. DURING THE PROCEDURE, THE BALLON BROKE AT 8 ATM. IT WAS FURTHER REPORTED THAT THE END OF THE BALLOON SEPARATED FROM THE OTHER END WHILE REMOVING. REPORTEDLY, IT WAS ABLE TO REMOVE THE SHEATH BY MAKING A SMALL INCISION AND PULLING THE BALLOON AND THE CATHETER OUT WITH QUITE A BIT OF FORCE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22640760 ↗
• MalfunctionMay 7, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS PTA DILATATION CATHETER. DURING THE PROCEDURE, PTA BALLOON WAS ALLEGEDLY NOT INFLATED. IT WAS FURTHER REPORTED THAT THE BALLOON MUST HAVE A HOLE IN IT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21974459 ↗
• MalfunctionMar 14, 2025Entrapment of Device; Material Rupture; Entrapment of Device; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY COULD HAVE GOTTEN CAUGHT ON THE STENT CAUSING A TEAR OR A RIP AT 18 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21603497 ↗
• MalfunctionJan 22, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON DILATATION CATHETER ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206332 ↗
• MalfunctionApr 18, 2024Entrapment of Device; Material Rupture; Entrapment of Device; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 2 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON WAS POSSIBLY SNAGGED ON THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19131591 ↗
• MalfunctionJul 23, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE BOX THAT CONTAINED THE BALLOON WAS ALLEGEDLY FOUND BENT IN MULTIPLE SPOTS. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15090272 ↗
• MalfunctionNov 1, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PRODUCT WAS ALLEGEDLY MISLABELED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12726217 ↗
• InjuryAug 3, 2021Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON CAME OFF FROM THE CATHETER AND COULD NOT BE RETRIEVED. ADDITIONAL SURGERY WAS UNDERGONE TO REMOVE THE DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 12264625 ↗
• MalfunctionMar 4, 2021Break; Retraction Problem; Break; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED STUCK IN 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 11408688 ↗
• MalfunctionMar 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE PATIENT'S LEFT UPPER ARM FISTULA, THE PTA BALLOON ALLEGEDLY BUSTED AT 15ATM. 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 11395172 ↗
• MalfunctionOct 9, 2018Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN AN AV GRAFT, THE PTA BALLOON ALLEGEDLY RUPTURED, AND SEQUENTIALLY HAD ISSUES RETRACTING THROUGH THE SHEATH. THE BALLOON AND SHEATH WERE REMOVED TOGETHER AS ONE UNIT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7950148 ↗
• MalfunctionAug 15, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED CIRCUMFERENTIALLY, AFTER AN ATTEMPT TO GAIN RETROGRADE ACCESS. NO FURTHER TREATMENT WAS NEEDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7784999 ↗
• MalfunctionMar 30, 2018Break; Break

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A LEFT FOREARM FISTULA, A BREAK WAS ALLEGEDLY IDENTIFIED AT THE JOINT BETWEEN THE CATHETER SHAFT AND THE BALLOON. THE BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7386110 ↗
• MalfunctionFeb 26, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PTA BALLOON CATHETER ALLEGEDLY RUPTURED AT 4 ATM. THERE WAS NO REPORTED RETRACTION DIFFICULTY THROUGH THE SHEATH. REPORTEDLY, ANOTHER BALLOON CATHETER WAS EXCHANGED OVER THE GUIDEWIRE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7298185 ↗