Vaccess® VA8084Recalls & reported problems
Bard Peripheral Vascular, Inc. · Vaccess® PTA Dilatation Catheter 8 mm x 40 mm, 80 cm Catheter · Class 2
Quick summary
This Vaccess balloon dilatation catheter is used to widen narrowed blood vessels, including fistula vessels, during angioplasty. The 36 reports mostly describe the balloon bursting during the procedure, sticking inside the sheath so it would not come out, or being hard to remove;4 reports mention injuries and none mention deaths. 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
- 35
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00801741121333), received between Aug 31, 2017 and Feb 17, 2026 — classified as 3 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (18 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
- Material Rupture18
- Retraction Problem11
- Difficult to Remove10
- Detachment of Device or Device Component8
- Deflation Problem7
- Break3
- Device-Device Incompatibility3
- Difficult to Insert2
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- No Consequences Or Impact To Patient14
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body In Patient1
- Injury1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionDec 24, 2025Difficult to Insert; Difficult to Remove; Device-Device Incompatibility; Difficult to Insert; Difficult to Remove; Device-Device Incompatibility
A PATIENT UNDERWENT ANGIOPLASTY PROCEDURE USING THE VACCESS PTA BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE THE BALLOON ALLEGEDLY GOT STUCK IN THE SHEATH AND WAS DIFFICULT TO REMOVE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23886477 ↗MalfunctionNov 6, 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, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23484178 ↗MalfunctionAug 13, 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, BOTH THE BALLOONS WERE RUPTURED BEFORE REACHING THE RATED BURST PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22792680 ↗MalfunctionAug 13, 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, BOTH THE BALLOONS WERE RUPTURED BEFORE REACHING THE RATED BURST PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22792678 ↗MalfunctionJul 4, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VACCESS PTA BALLOON CATHETER TO TREAT STENOSIS IN A FISTULA. DURING THE PROCEDURE, THE BALLOON WOULD NOT EXPAND, REMOVED FROM THE PATIENT AND INVESTIGATED AND A PIN HOLE WAS NOTICED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22403130 ↗MalfunctionJun 23, 2025Material Rupture; Material Rupture
ON (B)(6), 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ACCESS PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED BELOW BURST. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22305672 ↗MalfunctionJul 10, 2024Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY WOULD NOT DEFLATE ON PROXIMAL SIDE OF THE BALLOON. FURTHER IT WAS REPORTED THAT THERE WERE DIFFICULTY RETRACTING THE DEVICE THROUGH THE INTRODUCER SHEATH AND PULLED BALLOON AND SHEATH OUT AT SAME TIME THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19708316 ↗MalfunctionMay 13, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 19 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY WOULD NOT COME BACK THROUGH THE SHEATH, SO THE BALLOON AND THE SHEATH WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19296183 ↗MalfunctionMay 6, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY GOT STUCK IN THE SHEATH AND THE ENTIRE BALLOON AND THE SHEATH HAD TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19246857 ↗MalfunctionMay 6, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY GOT STUCK IN THE SHEATH AND THE ENTIRE BALLOON AND THE SHEATH HAD TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19246855 ↗InjuryMar 4, 2024Entrapment of Device; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Entrapment of Device; Difficult to Remove; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FOR A STENOSIS IN THE GRAFT, THE PTA BALLOON ALLEGEDLY RUPTURED, AND THE PARTIALLY DEFLATED BALLOON WAS ALLEGEDLY LODGED AT THE SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY DIFFICULT TO BE REMOVED THROUGH THE SHEATH. FURTHERMORE, WHEN TRIED TO REMOVE THE BALLOON THROUGH THE SHEATH, THE DISTAL TWO CENTIMETER OF THE BALLOON WITH THE SHAFT WERE ALLEGEDLY DETACHED. REPORTEDLY, THE MISSING PIECES OF THE BALLOON WERE ALLEGEDLY LOCATED AT THE DISTAL END OF THE STENT AND A STENT WAS PLACED WITH THE AIM OF COVERING THE FRAGMENTS AND TRAPPING THEM IN PLACE BETWEEN THE WALL OF THE VESSEL AND THE WALL OF THE STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 18824906 ↗MalfunctionDec 28, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18408951 ↗MalfunctionDec 13, 2022Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 16 ATM . IT WAS FURTHER REPORTED THAT BALLOON WAS DIFFICULT TO REMOVE THROUGH THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15967321 ↗MalfunctionDec 6, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED AT 18 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15922521 ↗MalfunctionNov 7, 2021Difficult to Remove; Material Rupture; Device-Device Incompatibility; Difficult to Advance; Difficult to Remove; Material Rupture; Device-Device Incompatibility; Difficult to Advance
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED AND WAS UNABLE TO BE REMOVED. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY GOT STUCK INSIDE 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 12757396 ↗MalfunctionJan 28, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED AT 18 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11242163 ↗MalfunctionJan 28, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED AT 18 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11242162 ↗MalfunctionJan 4, 2021Difficult to Insert; Retraction Problem; Device-Device Incompatibility; Difficult to Insert; Retraction Problem; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PROCEDURE THROUGH THE ARM, THE BALLOON ALLEGEDLY DID NOT PASS THROUGH THE INTRODUCER SHEATH AFTER THE FIRST INFLATION. IT WAS FURTHER REPORTED THAT THEY EXPERIENCED RETRACTION PROBLEM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11106786 ↗InjuryDec 8, 2020Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH UPPER ARM, THE PTA BALLOON ALLEGEDLY RUPTURED CIRCUMFERENTIALLY AT 15 ATM. THE PROCEDURE WAS COMPLETED BY REMOVING THE BALLOON AND THE PATIENT WAS SENT FOR SURGICAL REPAIR. THE PATIENT'S CURRENT STATUS WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10964471 ↗MalfunctionOct 23, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VA8084 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION PROBLEM AND DIFFICULT TO REMOVE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, WEIGHT AND GENDER OF THE PATIENT WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10730977 ↗MalfunctionJul 17, 2020Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL VA8084 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE AND LEAK. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. A (B)(6) YEAR OLD FEMALE PATIENT WEIGHS (B)(6) LBS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10292794 ↗MalfunctionApr 21, 2020Material 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 VA8084 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE (B)(6) YEAR OLD MALE PATIENT WEIGHED (B)(6) POUNDS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9980954 ↗MalfunctionApr 20, 2020Retraction Problem; Retraction Problem
THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VA8084 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE THREE MALFUNCTIONS INVOLVED A PATIENT WITH NO CONSEQUENCES. ONE PATIENT WAS A (B)(6) YEAR OLD FEMALE THAT WEIGHED (B)(6) POUNDS. THE REMAINING PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9979804 ↗MalfunctionApr 15, 2020Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VA8084 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT OF THE DEVICE OR A DEVICE COMPONENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS REPORTEDLY A 70 YEAR OLD FEMALE WEIGHING 204LBS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9962528 ↗
Other Catheter, angioplasty, peripheral, transluminal devices
- Coyote™ ES H74939135152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal879 reports
- Coyote™ ES H74939135204010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.