Vaccess® VA8074Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741121319), received between Mar 6, 2017 and Dec 18, 2025 — classified as 7 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE VACCESS PTA BALLOON. DURING THE PROCEDURE, THE BALLOON WOULD NOT ALLEGEDLY INFLATE. IT WAS FURTHER REPORTED THAT IT WAS DIFFICULT TO INFLATE BUT WOULD NOT DEFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836104 ↗
• MalfunctionJul 17, 2024Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DID NOT FULLY DEFLATE. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY RETRACTING THE DEVICE THROUGH THE INTRODUCER SHEATH OR REMOVING FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19759565 ↗
• MalfunctionJul 15, 2024Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DID NOT FULLY DEFLATE. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY RETRACTING THE DEVICE THROUGH THE INTRODUCER SHEATH OR REMOVING FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19739295 ↗
• MalfunctionJun 7, 2023Break; Break

  IT WAS REPORTED THAT DURING THE PREPARATION OF AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY BROKE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080785 ↗
• MalfunctionJan 16, 2023Break; Break

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY BROKE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16172539 ↗
• MalfunctionMar 30, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AND CONTRAST WAS LEAKED OUT OF THE BALLOON UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13947173 ↗
• MalfunctionMar 15, 2022Break; Break

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY HAD A BREAK IN THE CATHETER SHAFT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13768904 ↗
• MalfunctionMar 1, 2022Break; Break

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE CATHETER ALLEGEDLY BROKE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13627577 ↗
• MalfunctionMar 12, 2021Retraction Problem; Material Rupture; Detachment of Device or Device Component; Retraction Problem; Material Rupture; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11471856 ↗
• MalfunctionJul 17, 2020Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT THE MODEL VA8074 PTA BALLOON DILATATION CATHETER ALLEGEDLY HAD A DEFLATION ISSUE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT'S AGE, SEX AND WEIGHT WERE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10292632 ↗
• MalfunctionApr 15, 2020Retraction Problem; Detachment of Device or Device Component; Material Deformation; Retraction Problem; Detachment of Device or Device Component; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VA8074 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION AND RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS A 60 YEAR OLD MALE; WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9962621 ↗
• InjuryFeb 27, 2020Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE UPPER ARM, THE PTA BALLOON ALLEGEDLY RUPTURED AT 20 ATM, ON THE SECOND INFLATION ATTEMPT. IT WAS FURTHER REPORTED THAT DURING REMOVAL OF THE DEVICE, BALLOON MATERIAL DETACHED AND MIGRATED TO THE HEART. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL FOR RETRIEVAL OF THE DETACHED MATERIAL. THE PATIENT IS REPORTEDLY STABLE.

  Patient problems: Injury

  MAUDE report 9765816 ↗
• MalfunctionJan 14, 2020Retraction Problem; Material Rupture; Detachment of Device or Device Component; Retraction Problem; Material Rupture; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VA8074 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A MATERIAL RUPTURE, RETRACTION PROBLEM, AND DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9586365 ↗
• MalfunctionOct 18, 2019Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VA8074 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE 40 YEAR OLD MALE PATIENT WAS 165 LB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9210725 ↗
• InjurySep 19, 2019Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CEPHALIC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED ON THE FIRST INFLATION ATTEMPT. IT WAS FURTHER REPORTED THAT THERE WAS DETACHED MATERIAL, AND SURGICAL INTERVENTION WAS REQUIRED TO RETRIEVE THE DETACHED MATERIAL. THE PATIENT WAS REPORTEDLY STABLE.

  Patient problems: Injury

  MAUDE report 9090178 ↗
• InjurySep 12, 2019Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A VENOUS OUTFLOW GRAFT, THE PTA BALLOON ALLEGEDLY RUPTURED AND HAD DETACHED MATERIAL. IT WAS FURTHER REPORTED THAT THE PATIENT REQUIRED ADDITIONAL HOSPITALIZATION TO RETRIEVE THE DETACHED MATERIAL. THE PATIENT IS REPORTEDLY STABLE POST PROCEDURE.

  Patient problems: Injury

  MAUDE report 9009481 ↗
• InjurySep 11, 2019Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A VENOUS OUTFLOW GRAFT, THE PTA BALLOON ALLEGEDLY RUPTURED AND HAD DETACHED MATERIAL. IT WAS FURTHER REPORTED THAT THE PATIENT REQUIRED ADDITIONAL HOSPITALIZATION TO RETRIEVE THE DETACHED MATERIAL. THE PATIENT IS REPORTEDLY STABLE POST PROCEDURE.

  Patient problems: Injury

  MAUDE report 8998247 ↗
• InjuryMar 14, 2019Break; Peeled/Delaminated; Retraction Problem; Material Rupture; Break; Peeled/Delaminated; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY RUPTURED ON THE FIRST INFLATION ATTEMPT. IT WAS FURTHER REPORTED THAT THE BALLOON WAS UNABLE TO BE REMOVED THROUGH THE 6FR SHEATH. WHEN TRYING TO REMOVE THE BALLOON, THE OUTER LAYER OF THE BALLOON ALLEGEDLY PEELED OFF. A LARGE SHEATH WAS PLACED RETROGRADE CENTRAL TO THE ANTEGRADE SHEATH WITH THE BALLOON, AND THE RUPTURED BALLOON WAS SHARED AND PULLED OUT THROUGH THE RETROGRADE SHEATH. THE BALLOON HAD TO BE CUT CLOSE TO THE HUB IN ORDER TO PULL IT OUT THROUGH THE SECOND SHEATH. UPON REMOVING THE BALLOON AND SHEATH FROM THE PATIENT, THE PATIENT'S ACCESS SITE CLOTTED OFF AND STOPPED WORKING. THE PATIENT WAS ADMITTED TO THE HOSPITAL TO HAVE A THROMBECTOMY THE FOLLOWING DAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8421995 ↗
• MalfunctionApr 13, 2018Break; Retraction Problem; Detachment of Device or Device Component; Break; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY FOUND DETACHED FROM THE CATHETER UPON REMOVING THE DEVICE FROM THE PACKAGING. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS PERFORMED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 7429706 ↗
• MalfunctionDec 15, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A LEFT BRACHIOCEPHALIC FISTULA, THE PTA BALLOON ALLEGEDLY RUPTURED AT 12ATM. THE PTA 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 7121575 ↗
• InjuryJun 27, 2017Break; Retraction Problem; Material Rupture; Break; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT THE DURING THE FIRST INFLATION, THE PTA BALLOON CATHETER ALLEGEDLY RUPTURED (ATM UNK) IN A A/V GRAFT FISTULA. DURING REMOVAL THE PTA BALLOON WAS DIFFICULTY TO RETRACT AND STARTED TO ACCORDION AT THE INTRODUCER SHEATH; THEREFORE, THE HCP PERFORMED A CUTDOWN ON THE VESSEL AND REMOVED THE BALLOON AND SHEATH AS ONE UNIT. THE HCP DEPLOYED A STENT GRAFT AND ESTABLISHED PATENCY OF THE VESSEL WITH GOOD FLOW. THE PATIENT WAS REPORTEDLY DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6670977 ↗
• InjuryMar 6, 2017Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY DETACHED FROM THE CATHETER SHAFT. REPORTEDLY, THE HEALTH CARE PROVIDER USED A COVERED STENT TO PIN THE BALLOON SEGMENT TO THE VESSEL WALL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6380835 ↗