VaccessRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 328
- Deaths reported
- 0
- Injuries reported
- 62
- Recalls
- 0
We found 25 models of Vaccess by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 328 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2016 and Aug 13, 2026 — classified as 62 injuries, 266 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (152 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Vaccess problems
Device problems
- Material Rupture152
- Retraction Problem99
- Difficult to Remove84
- Detachment of Device or Device Component78
- Deflation Problem69
- Break52
- Material Deformation33
- Difficult to Insert10
Patient problems
- No Clinical Signs, Symptoms or Conditions167
- No Consequences Or Impact To Patient111
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available23
- Injury11
- No Known Impact Or Consequence To Patient10
- No Patient Involvement4
- Foreign Body In Patient3
- Hemorrhage/Blood Loss/Bleeding3
Vaccess models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Vaccess® VA8088Catheter, angioplasty, peripheral, transluminal60 reports
- Vaccess® VA80124Catheter, angioplasty, peripheral, transluminal60 reports
- Vaccess® VA80104CATHETER, PERCUTANEOUS48 reports
- Vaccess® VA8094CATHETER, PERCUTANEOUS45 reports
- Vaccess® VA8084Catheter, angioplasty, peripheral, transluminal35 reports
- Vaccess® VA8074CATHETER, PERCUTANEOUS22 reports
- Vaccess® VA8078Catheter, angioplasty, peripheral, transluminal14 reports
- Vaccess® VA8064Catheter, angioplasty, peripheral, transluminal6 reports
- Vaccess® VA8086CATHETER, PERCUTANEOUS6 reports
- Vaccess® VA8076Catheter, angioplasty, peripheral, transluminal4 reports
- Vaccess® VA5084CATHETER, PERCUTANEOUS3 reports
- Vaccess® VA50104Catheter, angioplasty, peripheral, transluminal3 reports
- Vaccess® VA8068CATHETER, PERCUTANEOUS3 reports
- Vaccess® VA80104RCatheter, angioplasty, peripheral, transluminal3 reports
- Vaccess® VA5054CATHETER, PERCUTANEOUS2 reports
- Vaccess® VA5064Catheter, angioplasty, peripheral, transluminal2 reports
- Vaccess® VA5088CATHETER, PERCUTANEOUS2 reports
- Vaccess® VA8064RCATHETER, PERCUTANEOUS2 reports
- Vaccess® VA8072CATHETER, PERCUTANEOUS2 reports
- Vaccess® VA5074CATHETER, PERCUTANEOUS1 report
- Vaccess® VA8062CATHETER, PERCUTANEOUS1 report
- Vaccess® VA8074RCatheter, angioplasty, peripheral, transluminal1 report
- Vaccess® VA8086RCATHETER, PERCUTANEOUS1 report
- Vaccess® VA8094RCatheter, angioplasty, peripheral, transluminal1 report
- Vaccess® VA80124RCATHETER, PERCUTANEOUS1 report
Recent Vaccess adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗MalfunctionAug 10, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50189866 ↗MalfunctionAug 10, 2026Material Rupture
On (b)(6) 2026, a 62 year old Hispanic male patient underwent a percutaneous transluminal angioplasty (PTA) procedure using a Vaccess balloon catheter. During the procedure, the balloon allegedly experienced a pinhole rupture. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50189804 ↗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 ↗MalfunctionMar 5, 2026Difficult to Remove
THE PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY STUCK TO 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 24516311 ↗MalfunctionFeb 17, 2026Deflation Problem; Difficult to Remove
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE VACCESS PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY BALLOON WOULD NOT COME OUT THROUGH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24361366 ↗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 29, 2026Deflation Problem; Leak/Splash; Material Puncture/Hole; Difficult to Remove
IT WAS REPORTED THAT, A 48-YR OLD MALE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE BY USING THE VACCESS PTA BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON ALLEGEDLY WOULD NOT FULLY DEFLATE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24208055 ↗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 ↗
Other Bard Peripheral Vascular, Inc. products
- MAX-CORE11 models · 8,845 reports · 1 recall
- DENALI Vena Cava Filter2 models · 1,021 reports
- MAGNUM19 models · 571 reports · 1 recall
- Conquest32 models · 560 reports
- Ultraverse RX56 models · 536 reports
- Fluency Endovascular Stent Graft51 models · 532 reports
- Atlas Gold33 models · 427 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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