Vaccess® VA80124RRecalls & 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
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741060038), received between Oct 6, 2016 and Oct 6, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
- Material Rupture1
- Retraction Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 6, 2016Retraction Problem; Material Rupture; Detachment of Device or Device Component; Retraction Problem; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A LEFT UPPER ARM AV FISTULA, THE PTA BALLOON ALLEGEDLY RUPTURED (ATM UNKNOWN). REPORTEDLY, AS THE HEALTH CARE PROVIDER(HCP) WAS RETRACTING THE BALLOON THROUGH THE SHEATH, A SMALL SEGMENT OF THE BALLOON DETACHED AND TRAVELED PROXIMAL TO THE CEPHALIC VEIN. THE HCP USED A SNARE DEVICE IN AN ATTEMPT TO REMOVE THE BALLOON SEGMENT, BUT WAS UNSUCCESSFUL. THE HCP THEN USED A STENT TO PIN THE BALLOON SEGMENT AGAINST THE VESSEL WALL. REPORTEDLY, THE HCP USED ANOTHER BALLOON TO COMPLETE THE ANGIOPLASTY PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6003097 ↗
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- 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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