Vaccess® VA5088Recalls & reported problems
Bard Peripheral Vascular, Inc. · Vaccess® PTA Dilatation Catheter 8 mm x 80 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741059735), received between Nov 7, 2019 and Nov 20, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Deflation Problem” (2 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
- Deflation Problem2
- Material Deformation2
- Retraction Problem2
Patient problems
- Needle Stick/Puncture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2019Deflation Problem; Retraction Problem; Material Deformation; Deflation Problem; Retraction Problem; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD A DEFLATION ISSUES. IT WAS FURTHER REPORTED THE DISTAL TIP OF THE BALLOON WAS LARGER THAN THE BODY OF THE BALLOON. REPORTEDLY, THE BALLOON ALSO EXPERIENCED RETRACTION ISSUES. A NEEDLE WAS USED TO PUNCTURE THE BALLOON AND THEN BEING REMOVED FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE PATIENT IS MEDICALLY STABLE.
Patient problems: Needle Stick/Puncture
MAUDE report 9350515 ↗InjuryNov 7, 2019Deflation Problem; Retraction Problem; Material Deformation; Deflation Problem; Retraction Problem; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD A DEFLATION ISSUE. IT WAS FURTHER REPORTED THE DISTAL TIP OF THE BALLOON WAS LARGER THAN THE BODY OF THE BALLOON. REPORTEDLY, THE BALLOON ALSO EXPERIENCED RETRACTION ISSUES. A NEEDLE STICK WAS USED TO DEFLATE THE BALLOON PERCUTANEOUSLY AND THE DEVICE WAS REMOVED FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE PATIENT IS MEDICALLY STABLE.
Patient problems: Needle Stick/Puncture
MAUDE report 9291140 ↗
Other CATHETER, PERCUTANEOUS devices
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- WATCHMAN TruSteer™ Access System M635TU90050Boston Scientific Corporation · Catheter, percutaneous1 recall28 deaths302 reports
- Guidezilla™ II H7493933515060Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
- Velocity Delivery Microcatheter VEL160STR-APenumbra, Inc. · CATHETER, PERCUTANEOUS297 reports
- Guidezilla™ H7493924215050Boston Scientific Corporation · CATHETER, PERCUTANEOUS294 reports
- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 reports
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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