Vaccess® VA80104Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00801741121258), received between Sep 28, 2016 and Dec 24, 2025 — classified as 15 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (29 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 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, IT WAS REPORTED THAT THE BALLOON WOULDN'T INFLATE PAST 8 ATM AND CONTRAST STARTED LEAKING OUT OF BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23886628 ↗
• MalfunctionOct 27, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A 77-YEAR-OLD FEMALE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE VACCESS PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389113 ↗
• MalfunctionOct 21, 2025Difficult to Remove; Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE VACCESS PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY GOT STUCK IN SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON COULD NOT BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23346908 ↗
• MalfunctionOct 8, 2025Difficult to Remove; Difficult to Remove

  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 GOT STUCK IN THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23242439 ↗
• MalfunctionSep 8, 2025Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE VACCESS PTA BALLOON. IT WAS REPORTED THAT DURING REMOVAL, THE BALLOON ALLEGEDLY BROKE APART. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22989764 ↗
• MalfunctionMar 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT COMMON FEMORAL ARTERY, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 6 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511111 ↗
• InjuryApr 24, 2024Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN LEFT UPPER ARM ARTERIOVENOUS FISTULA, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT PATIENT HAD SENSATION OF CHEST BURNING AND DEVELOPED WITH HEMOPTYSIS. REPORTEDLY, THE BALLOON ALLEGEDLY SHEARED OFF UPON REMOVAL. FURTHERMORE, CHEST CT SHOWED THAT THE EXTRALUMINAL CATHETER FRAGMENT WAS FOUND IN MEDIASTINAL FAT. PATIENT WAS TRANSFERRED TO A CRITICAL CARE FOR MONITORING AND PATIENT EXPERIENCED THROAT SWELLING, COUGH AND TREATED WITH PREDNISONE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient; Swelling/ Edema

  MAUDE report 19170018 ↗
• MalfunctionApr 11, 2024Material 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 19086199 ↗
• MalfunctionDec 9, 2023Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON HAD ALLEGEDLY RUPTURED AT 10 ATM DURING THE SECOND INFLATION. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD AN ISSUE REMOVING THE BALLOON BUT WAS ABLE TO RETRIEVE IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18298157 ↗
• MalfunctionOct 9, 2023Break; Difficult to Insert; Material Deformation; Break; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON CATHETER ALLEGEDLY HAD A DEFORMATION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17893404 ↗
• MalfunctionSep 26, 2023Difficult to Insert; Difficult to Remove; Material Rupture; Device-Device Incompatibility; Material Deformation; Difficult to Insert; Difficult to Remove; Material Rupture; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CEPHALIC ARCH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 15 ATM AND WAS ONLY ABLE TO INFLATE TO 10 ATM PRIOR TO BURSTING. IT WAS FURTHER REPORTED THAT IN AN ATTEMPT TO RETRIEVE THE BALLOON CATHETER, THE BALLOON WAS UNABLE TO BE RETRACTED TOTALLY TO ALLOW PASSING THROUGH THE SHEATH. REPORTEDLY, THE HEALTH CARE PERSONNEL PROCEEDED TO REMOVE THE SHEATH OVER THE WIRE AND THEN REMOVED THE BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17819020 ↗
• MalfunctionJun 28, 2023Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215239 ↗
• MalfunctionAug 18, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN LEFT ARM, THE PTA BALLOON ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THE DEVICE WAS REMOVED USING SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15247501 ↗
• MalfunctionJul 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA A LEFT UPPER ARM BRACHIOCEPHALIC ARTERIOVENOUS FISTULA, TO TREAT A STENOTIC LESION IN THE CEPHALIC ARCH, THE BALLOON ALLEGEDLY RUPTURED AT 8 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127875 ↗
• InjuryApr 26, 2022Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY BURST AT 12 ATM. IT WAS FURTHER REPORTED THAT THE DEVICE HAD RETRACTION ISSUE. REPORTEDLY PATIENT EXPERIENCED VESSEL INJURY, BLEEDING, RIGHT SIDE CHEST AND SHOULDER SWOLLEN AND BRUISED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bruise/Contusion; Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels; Swelling/ Edema

  MAUDE report 14202163 ↗
• MalfunctionApr 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE UPPER ARM FISTULA, THE TIP OF THE BALLOON ALLEGEDLY BROKE OFF UPON INFLATION. IT WAS FURTHER REPORTED THAT THE TIP OF THE BALLOON WAS RETRIEVED WITH A SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13995408 ↗
• MalfunctionMar 31, 2022Difficult 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 IN A UPPER ARM FISTULA, THE TIP OF THE BALLOON WAS ALLEGEDLY BROKE UPON INFLATION. IT WAS FURTHER REPORTED THAT THEY WERE ABLE TO RETRIEVE THE TIP WITH A SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13961871 ↗
• InjuryJul 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ANGIOPLASTY THE PTA BALLOON ALLEGEDLY DETACHED FROM THE CATHETER. REPORTEDLY, A SNARE WAS USED TO REMOVE THE BALLOON FROM THE PATIENT. IT WAS FURTHER REPORTED AN ADDITIONAL SURGICAL PROCEDURE WAS SCHEDULED TO COMPLETE THE ANGIOPLASTY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 12133497 ↗
• MalfunctionMar 15, 2021Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED AT 10 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY HAD RETRACTION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11482981 ↗
• MalfunctionJul 22, 2020Deflation Problem; Retraction Problem; Deflation Problem; Retraction Problem

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VA80104 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION PROBLEM AND RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE WEIGHT OF (B)(6) YEAR OLD MALE IS (B)(6) POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10308244 ↗
• InjuryJun 30, 2020Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED, IT WAS FURTHER REPORTED THAT THE BALLOON WAS STUCK IN THE SHEATH AND UPON REMOVAL THE PATIENT WAS INJURED CAUSING SUTURES. THE SUTURES WERE LATER CLOSED. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Suture Abrasion

  MAUDE report 10210603 ↗
• InjuryMay 6, 2020Deflation Problem; Retraction Problem; Deflation Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY EXPERIENCED A DEFLATION ISSUE. IT WAS FURTHER REPORTED THAT THE DEVICE EXPERIENCED RETRACTION ISSUES THROUGH THE SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON TORE THE VESSEL AT THE ACCESS SITE UPON REMOVAL. REPORTEDLY, THE HEALTH CARE PROVIDER APPLIED MANUAL PRESSURE FOR 10 MINUTES AND STITCHED THE VEIN TO CONTROL THE BLEEDING. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Blood Loss; Rupture

  MAUDE report 10030812 ↗
• MalfunctionApr 20, 2020Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VA80104 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A MATERIAL RUPTURE AND A RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE AGE AND WEIGHT OF THE FEMALE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9979599 ↗
• MalfunctionApr 15, 2020Deflation Problem; Retraction Problem; Deflation Problem; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VA80104 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION PROBLEM AND RETRACTION PROBLEM. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9962529 ↗
• MalfunctionApr 13, 2020Retraction Problem; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE INFORMATION INDICATES THAT MODEL VA80104 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED A RETRACTION PROBLEM. THE INFORMATION CAME FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9953765 ↗