Vaccess® VA50104Recalls & reported problems
Bard Peripheral Vascular, Inc. · Vaccess® PTA Dilatation Catheter 10 mm x 40 mm, 50 cm Catheter · Class 2
All models of Vaccess (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741059773), received between Jun 12, 2017 and Apr 27, 2021 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (3 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.
Most reported problems
Device problems
- Material Rupture3
- Detachment of Device or Device Component1
- Difficult to Remove1
- Retraction Problem1
Patient problems
- No Consequences Or Impact To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2021Difficult 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 DEVICE ALLEGEDLY HAD A BALLOON RUPTURE. ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE DETACHED COMPONENT. THE PATIENT'S CURRENT STATUS WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 11730400 ↗MalfunctionOct 18, 2017Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY RUPTURED PRIOR TO REACHING THE RATED BURST PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6960175 ↗MalfunctionJun 12, 2017Retraction Problem; Material Rupture; Retraction Problem; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE BRACHIOCEPHALIC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10 ATM AND WAS SUBSEQUENTLY DIFFICULT TO RETRACT FROM THE SHEATH. THE BALLOON AND SHEATH WERE REMOVED TOGETHER AS ONE UNIT. NO FURTHER TREATMENT WAS REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6635388 ↗
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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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