Ultraverse® RX U4200330RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 3 mm x 300 mm, 200 cm Catheter · Class 2
All models of Ultraverse RX (56)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741057052), received between Oct 25, 2017 and Jul 17, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component2
- Device-Device Incompatibility1
- Difficult to Advance1
- Difficult to Remove1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE SHAFT OF THE PTA BALLOON ALLEGEDLY BROKE ABOUT ONE-THIRD OF THE WAY DOWN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19767929 ↗MalfunctionSep 6, 2021Difficult to Remove; Device-Device Incompatibility; Difficult to Advance; Material Deformation; Difficult to Remove; Device-Device Incompatibility; Difficult to Advance; Material Deformation
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE DEVICE WAS ALLEGEDLY DIFFICULT TO ADVANCE BEFORE ENTERING INTO THE SHEATH. IT WAS FURTHER REPORTED THAT THE DEVICE HAD INCOMPATIBILITY ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12428426 ↗MalfunctionOct 25, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY, THE PTA BALLOON SHAFT ALLEGEDLY BROKE PRIOR TO INFLATION. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6976604 ↗
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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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