Vaccess® VA8094Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00801741121357), received between Nov 21, 2016 and Aug 12, 2026 — classified as 15 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Difficult to Remove; Material Deformation

  A patient underwent an angioplasty procedure using the Vaccess PTA balloon. During the procedure, the balloon allegedly burped twice. It was further reported that the balloon seems to telescope at the end increasing the diameter of the balloon. The procedure was completed using another balloon. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50219034 ↗
• MalfunctionNov 3, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23446942 ↗
• MalfunctionAug 14, 2025Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Material Deformation; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Material Deformation

  A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CAME OFF THE SHAFT COMPLETELY INSIDE A PATIENT. IT WAS FURTHER REPORTED THAT HAD TO SPEND OVER AN HOUR TRYING TO RETRIEVE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22802046 ↗
• MalfunctionJul 31, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677278 ↗
• MalfunctionMay 28, 2025Difficult to Insert; Difficult to Remove; Device-Device Incompatibility; Difficult to Insert; Difficult to Remove; Device-Device Incompatibility

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY GOT STUCK IN SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094274 ↗
• InjuryMay 26, 2025Break; Difficult to Remove; Material Rupture; Break; Difficult to Remove; Material Rupture

  ON (B)(6) 2025, AN (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED AT 16 ATM INSIDE A PATIENT ON FOURTH INFLATION ATTEMPT. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED VESSEL TRAUMA AND WAS SENT TO HOSPITAL TO HAVE RUPTURED BALLOON REMOVED AND ANOTHER BALLOON WAS INFLATED TO BLOCK ANY OF THE RUPTURED BALLOON FROM MIGRATING. REPORTEDLY, THERE WAS A COMPONENT DETACHMENT ISSUES AND THERE WAS A DIFFICULTY IN RETRACTING THE BALLOON THRU THE SHEATH. THE CURRENT STATUS OF THE PATIENT IS STABLE, BUT THE PATIENT LOST THE FISTULA.

  Patient problems: Perforation of Vessels

  MAUDE report 22083146 ↗
• MalfunctionMar 20, 2025Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650400 ↗
• MalfunctionDec 16, 2024Difficult to Insert; Difficult to Remove; Device-Device Incompatibility; Material Deformation; Difficult to Insert; Difficult to Remove; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE TIP OF PTA BALLOON WAS ALLEGEDLY DEFORMED AND WOULD NOT PASS THRU SHEATH UPON REMOVAL FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED WITH DIFFICULTY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20936095 ↗
• MalfunctionOct 18, 2024Difficult to Remove; Material Rupture; Material Deformation; Difficult to Remove; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 16 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY COLLAPSED AT THE SHEATH WHEN PULLING IT OUT. FURTHERMORE, IT WAS ALLEGEDLY DIFFICULT WHILE REMOVING THE DEVICE. REPORTEDLY, THE SHEATH WAS REINSERTED, AND AN ADDITIONAL BALLOON WAS USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20478987 ↗
• MalfunctionSep 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE PATIENT¿S OUTFLOW BASILIC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AFTER THIRD INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146328 ↗
• MalfunctionJun 10, 2024Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY BURST. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY DETACHED AND ALL THE FRAGMENTS WERE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19496378 ↗
• MalfunctionJun 5, 2024Difficult to Insert; Difficult to Remove; Material Rupture; Device-Device Incompatibility; Difficult to Insert; Difficult to Remove; Material Rupture; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD RESISTANCE INSERTING THE SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY HAD A HOLE AND THE CONTRAST LEAKED OUT BEFORE IT WAS FULLY INFLATED DURING THE INITIAL INFLATION. REPORTEDLY, THE SHEATH WAS ALLEGEDLY STUCK UPON RETRIEVAL AND THERE WAS SIGNIFICANT RESISTANCE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19465922 ↗
• MalfunctionMar 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY POPPED BELOW MAX PRESSURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825090 ↗
• MalfunctionSep 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED LONGITUDINALLY PRIOR TO INFLATION OF THE VESSEL. IT WAS FURTHER REPORTED THAT THERE WERE NO DETACHMENT AND DIFFICULTY IN REMOVING THE BALLOON THROUGH SHEATH. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17763057 ↗
• MalfunctionJul 14, 2023Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER SHAFT ALLEGEDLY HAD A BREAK. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD A LEAK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17327694 ↗
• MalfunctionMay 18, 2023Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Material Deformation; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON MUSHROOMED WHEN ATTEMPTING TO REMOVE IT FROM THE SHEATH AND FORCED TO REMOVE THE SHEATH. REPORTEDLY, UPSIZE IN SHEATH WAS NECESSARY, BECAUSE THE REMOVAL OF THE BALLOON CAUSED A BIGGER HOLE IN THE VESSEL. HOWEVER, THERE IS NO INFORMATION PROVIDED REGARDING ADDITIONAL INTERVENTION OR MEDICATION TO TREAT THE HOLE IN THE VESSEL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16951784 ↗
• MalfunctionJan 31, 2023Deflation Problem; Entrapment of Device; Difficult to Remove; Material Deformation; Deflation Problem; Entrapment of Device; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY STUCK IN A PATIENT AND WOULDN¿T DEFLATE ALL THE WAY. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY DIFFICULT TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270098 ↗
• MalfunctionApr 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN A STENOSIS IN A FISTULA OUTFLOW, THE PTA BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14186183 ↗
• MalfunctionFeb 16, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED AND DETACHED AND A PIECE OF IT WAS LEFT IN THE STENT. IT WAS FURTHER REPORTED THAT IT WAS NOT ABLE TO BE RETRIEVED HENCE ANOTHER STENT WAS PLACED OVER IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13540528 ↗
• InjuryDec 7, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD DEFLATION PROBLEM. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY GOT STUCK IN THE SHEATH AND A BLADE WAS USED TO CUT THE ACCESS SITE TO REMOVE BALLOON AND SHEATH. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 12947985 ↗
• InjuryDec 7, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD DEFLATION PROBLEM. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY GOT STUCK IN THE SHEATH AND A BLADE WAS USED TO CUT THE ACCESS SITE TO REMOVE BALLOON AND SHEATH. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 12947977 ↗
• InjuryDec 7, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD DEFLATION PROBLEM. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY GOT STUCK IN THE SHEATH AND A BLADE WAS USED TO CUT THE ACCESS SITE TO REMOVE BALLOON AND SHEATH. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 12947976 ↗
• InjuryDec 3, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY HAD DEFLATION ISSUE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY GOT STRUCK IN THE SHEATH. REPORTEDLY, THE ACCESS SITE WAS CUT USING THE BLADE 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 12922348 ↗
• InjuryNov 11, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH ARTERIAL APPROACH, THE DEVICE ALLEGEDLY HAD A DEFLATION ISSUE. IT WAS FURTHER REPORTED THAT BLEEDING ISSUES OCCURRED POST PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12795173 ↗
• InjuryOct 13, 2021Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED AT 2 ATM AND THE TIP AND BOTTOM PORTION OF THE BALLOON BROKE OFF INTO THE PATIENT. IT WAS FURTHER REPORTED THAT THE BROKEN PIECE WAS RETRIEVED FROM PATIENT THROUGH SURGICAL INTERVENTION. THE CURRENT PATIENT STATUS WAS UNKNOWN.

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

  MAUDE report 12624102 ↗