Vaccess® VA80124Recalls & reported problems
Bard Peripheral Vascular, Inc. · Vaccess® PTA Dilatation Catheter 12 mm x 40 mm, 80 cm Catheter · Class 2
All models of Vaccess (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Vaccess balloon dilatation catheter is used to open narrowed blood vessels during angioplasty. The 60 reports mostly describe the balloon bursting during the procedure, sticking or failing to deflate, and being hard to pull back out, sometimes requiring extra tools to retrieve. Ten reports involved injuries and none described a death. No recalls name this device.
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
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00801741121265), received between Oct 19, 2016 and Aug 10, 2026 — classified as 10 injuries, 50 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (37 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture37
- Detachment of Device or Device Component20
- Difficult to Remove18
- Break10
- Retraction Problem10
- Deflation Problem6
- Material Deformation5
- Inflation Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- No Consequences Or Impact To Patient15
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Injury2
- No Patient Involvement2
- Foreign Body In Patient1
- Hemorrhage/Blood Loss/Bleeding1
- Perforation of Vessels1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗InjuryDec 29, 2025Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE VACCESS PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED INSIDE THE PATIENT AND IT WAS DIFFICULT TO REMOVE FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE DISTAL PORTION OF THE RUPTURED BALLOON WAS NOT ABLE TO BE RETRACTED THROUGH THE 7 FR SHEATH. THE BALLOON WAS ONLY RETRIEVED BY MANUALLY GRASPING THE BALLOON WITH HEMOSTATS THROUGH THE VENOTOMY. THE CURRENT STATUS OF PATIENT WAS UNKNOWN.
Patient problems: Vascular Dissection
MAUDE report 23904302 ↗MalfunctionNov 19, 2025Break; Inflation Problem; Difficult to Remove; Break; Inflation 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 INFLATE AND GOT STUCK IN THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23592743 ↗MalfunctionNov 19, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE PTA VACCESS BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON GOT BURST. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23591694 ↗MalfunctionNov 19, 2025Peeled/Delaminated; Peeled/Delaminated
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE PTA VACCESS BALLOON. DURING PROCEDURE, WHILE FLUSHING THE FIBRES OF ANOTHER BALLOON WERE EXPELLED FROM THE SHAFT. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23591693 ↗MalfunctionNov 19, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE PTA VACCESS BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON GOT BURST. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23591692 ↗MalfunctionNov 11, 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 23520533 ↗MalfunctionOct 31, 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 FOR A ANGIOPLASTY PROCEDURE USING THE VACCESS PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY GOT STUCK IN THE SHEATH AND DIFFICULT TO REMOVE OR INSERT FURTHER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23434357 ↗MalfunctionOct 15, 2025Difficult to Remove; Difficult to Remove
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY GOT STUCK ON THE SHEATH. IT WAS FURTHER REPORTED THAT AS THE BALLOON WAS UNABLE TO REMOVE, SO IT WAS PULLED ALONG WITH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23298420 ↗MalfunctionSep 24, 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 AND DIFFICULT TO PULL THROUGH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23130340 ↗InjurySep 16, 2025Break; Entrapment of Device; Material Rupture; Detachment of Device or Device Component; Break; Entrapment of Device; Material Rupture; Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS PTA BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON WAS INFLATED AND THEN TOTALLY DEFLATED. AS THE BALLOON WAS PULLED BACK OUT OF THE STENT, THE BALLOON GOT CAUGHT ON A STENT STRUT. IT WAS FURTHER REPORTED THAT THE BALLOON THEN BROKE IN HALF AND PART OF THE TIP REMAINED IN THE VESSEL AS THEY PULLED THE WHOLE BALLOON OUT OF THE BODY. THE PATIENT THEN STARTED TO BLEED PROFUSELY, AND THEY HAD TO APPLY A TOURNIQUET. THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE A VASCULAR SURGEON WAS ABLE TO TAKE THE BROKEN OFF TIP OUT OF THE VESSEL. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23062373 ↗MalfunctionJul 29, 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 22642670 ↗MalfunctionMay 6, 2025Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Material Deformation; Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING VACCESS, DURING THE PROCEDURE, THE PTA CATHETER BALLOON WAS ALLEGEDLY DETACHED FROM THE CATHETER. IT WAS FURTHER REPORTED THAT HAD TO TAKE EVERYTHING OUT TO RETRIEVE THE TIP. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21966795 ↗InjuryApr 21, 2025Difficult 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 TIP OF THE BALLOON WAS ALLEGEDLY DETACHED FROM THE CATHETER. IT WAS FURTHER REPORTED THAT THEY HAD TO REMOVE THE SHEATH WITH THE BALLOON AND THEN OPEN THE AREA TO REMOVE THE PIECE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21873050 ↗InjuryMar 3, 2025Difficult 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 WAS ALLEGEDLY RUPTURED AFTER THE SECOND INFLATION UP TO 8 ATM. IT WAS FURTHER REPORTED THAT WHEN REMOVING THE PTA BALLOON THROUGH THE INTRODUCER SHEATH, HALF OF PTA BALLOON WAS TEARED AT THE TIP OF THE SHEATH IN THE PATIENT, AND THEY HAD TO REMOVE THE SHEATH WITH MOST OF THE PTA BALLOON EXCEPT FOR THE TIP. REPORTEDLY, LARGER ENTRY SITE WAS CREATED BY MAKING AN INCISION AND THE PTA BALLOON TIP WAS REMOVED USING FORCEPS. THE CURRENT STATUS OF THE PATIENT IS REPORTED TO BE STABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21503075 ↗MalfunctionFeb 14, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUBCLAVIAN VEIN, THE PTA BALLOON WAS ALLEGEDLY RUPTURED BEFORE REACHING BURST PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21390172 ↗MalfunctionJan 23, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21215961 ↗MalfunctionJan 13, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON CATHETER WAS ALLEGEDLY RUPTURED APPROXIMATELY AT 12 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21134571 ↗MalfunctionJan 6, 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 21076807 ↗MalfunctionNov 26, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE BRACHIOCEPHALIC VEIN VIA SUPERIOR VENA CAVA JUNCTION, THE PTA BALLOON ALLEGEDLY RUPTURED BELOW THE NOMINAL PRESSURE AT 4 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20783660 ↗MalfunctionJul 23, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED AT 8 ATM. IT WAS FURTHER REPORTED THAT THERE WAS AN DIFFICULTY IN REMOVING THE BALLOON FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19803137 ↗MalfunctionApr 16, 2024Difficult 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
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY WAS UNABLE TO PULL THROUGH THE SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON AND SHEATH WAS REMOVED TOGETHER AND USED A SUTURE TO CLOSE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19114091 ↗MalfunctionMar 18, 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 WAS ALLEGEDLY RUPTURED AT 10 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY HAD DETACHMENT ISSUES AND HAD A HARD TIME DEFLATING THE BALLOON AND HAD TO NUMB ANOTHER OF THE PATIENT'S ARM AND USE A MICRO PUNCTURE NEEDLE TO PUNCTURE THE BALLOON TO HELP DEFLATE IT AND GET IT OUTSIDE OF THE SHEATH. FURTHERMORE, THE BALLOON WAS ALLEGEDLY DIFFICULT TO BE REMOVED FROM THE PATIENT. REPORTEDLY, THE BALLOON WAS DEFLATED AND REMOVED FIRST, FOLLOWED BY REMOVAL OF THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18920392 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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