Vaccess® VA8088Recalls & reported problems
Bard Peripheral Vascular, Inc. · Vaccess® PTA Dilatation Catheter 8 mm x 80 mm, 80 cm Catheter · Class 2
Quick summary
This Vaccess balloon dilatation catheter is used to widen narrowed blood vessels in the arm or leg during angioplasty. The 61 reports mostly describe the balloon sticking or failing to deflate so it cannot be pulled back out of the sheath, along with balloon rupture, cracking, and tip collapse. Four reports involve an injury; no deaths are described. No recalls name this device. Reports rose from 3 in the prior 12 months to 20 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 60
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00801741059971), received between Oct 19, 2016 and Aug 13, 2026 — classified as 4 injuries, 56 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (26 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.
Reports received per month
Most reported problems
Device problems
- Deflation Problem26
- Difficult to Remove26
- Retraction Problem20
- Material Rupture11
- Break10
- Material Deformation9
- Detachment of Device or Device Component6
- Inflation Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- No Consequences Or Impact To Patient22
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Extravasation1
- Injury1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233530 ↗MalfunctionJun 9, 2026Deflation Problem; Difficult to Remove
A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER FAILED TO DEFLATE, PREVENTING ITS REMOVAL. AS A RESULT, THE ENTIRE SHEATH AND BALLOON CATHETER HAD TO BE REMOVED TOGETHER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25439282 ↗MalfunctionFeb 10, 2026Material Rupture
A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE VACCESS PTA BALLOON. DURING THE PROCEDURE, IT WAS REPORTED THAT 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 24301881 ↗MalfunctionFeb 2, 2026Difficult to Remove; Material Deformation
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER WAS ALLEGEDLY UNABLE TO BE REMOVED FROM 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 24232125 ↗MalfunctionJan 16, 2026Material Rupture; Detachment of Device or Device Component
A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE VACCESS PTA BALLOON. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24091192 ↗MalfunctionJan 13, 2026Deflation Problem; Difficult to Remove
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER WAS ALLEGEDLY UNABLE TO BE REMOVED FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24050373 ↗MalfunctionJan 13, 2026Deflation Problem; Difficult to Remove
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER WAS ALLEGEDLY UNABLE TO BE REMOVED FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24050371 ↗MalfunctionJan 13, 2026Deflation Problem; Difficult to Remove
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER WAS ALLEGEDLY UNABLE TO BE REMOVED FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24050368 ↗MalfunctionDec 29, 2025Deflation Problem; Difficult to Remove; Material Deformation; Deflation Problem; Difficult to Remove; Material Deformation
A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE BY USING THE VACCESS BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY UNABLE TO DEFLATE AND DIFFICULTY TO REMOVE FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23904861 ↗MalfunctionDec 29, 2025Deflation Problem; Difficult to Remove; Material Deformation; Deflation Problem; Difficult to Remove; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE BY USING THE VACCESS BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY UNABLE TO DEFLATE AND DIFFICULTY TO REMOVE FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23904858 ↗MalfunctionDec 29, 2025Deflation Problem; Difficult to Remove; Material Deformation; Deflation Problem; Difficult to Remove; Material Deformation
A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE BY USING THE VACCESS BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY UNABLE TO DEFLATE AND DIFFICULTY TO REMOVE FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23904857 ↗MalfunctionDec 29, 2025Deflation Problem; Difficult to Remove; Material Deformation; Deflation Problem; Difficult to Remove; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE BY USING THE VACCESS BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY UNABLE TO DEFLATE AND DIFFICULTY TO REMOVE FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23904851 ↗MalfunctionDec 29, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE BY USING THE VACCESS BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY UNABLE TO DEFLATE AND STUCK IN SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23904724 ↗MalfunctionDec 26, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER ALLEGEDLY UNABLE TO DEFLATE AND WAS DIFFICULT TO REMOVE FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23894914 ↗MalfunctionDec 26, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER ALLEGEDLY UNABLE TO DEFLATE AND WAS DIFFICULT TO REMOVE FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23894911 ↗MalfunctionDec 26, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
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 CATHETER ALLEGEDLY UNABLE TO DEFLATE AND WAS DIFFICULT TO REMOVE FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23894898 ↗MalfunctionDec 26, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER ALLEGEDLY UNABLE TO DEFLATE AND WAS DIFFICULT TO REMOVE FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23894897 ↗MalfunctionDec 26, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER ALLEGEDLY UNABLE TO DEFLATE AND WAS DIFFICULT TO REMOVE FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23894896 ↗MalfunctionNov 28, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
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 UNABLE TO DEFLATE AND GOT STUCK AT THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23671112 ↗MalfunctionSep 30, 2025Difficult to Remove; Difficult to Remove
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE VACCESS PTA BALLOON. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON TIP WAS STICKING IN THE SHEATH AND DIFFICULT TO REMOVE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23178442 ↗MalfunctionSep 30, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE VACCESS PTA BALLOON. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON ALLEGEDLY HAD DEFLATION PROBLEM. IT WAS FURTHER REPORTED THAT THERE WAS ISSUE IN REMOVING THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23178391 ↗MalfunctionSep 8, 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 22990348 ↗MalfunctionOct 16, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PACKAGING ALLEGEDLY HAD TWO HOLES. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20459121 ↗MalfunctionDec 14, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT EXTERNAL ILIAC ARTERY VIA THE LEFT FEMORAL ARTERY ACCESS, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 5 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18325495 ↗MalfunctionJul 10, 2023Inflation Problem; Difficult to Remove; Material Deformation; Inflation Problem; Difficult to Remove; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY FAILED TO INFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY HAD DIFFICULTY REMOVING IT. REPORTEDLY, THE BALLOON AND THE WHOLE SHEATH WERE REMOVED TOGETHER. IT WAS FURTHER REPORTED THAT THE BALLOON WAS BUNCHED UP AT THE TIP. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17285070 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.