Ultraverse® RX U420024RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 2 mm x 40 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741056154), received between Jul 16, 2019 and Dec 19, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE COMMON FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY BROKE OFF IN THE PATIENT WHEN ATTEMPTED TO REMOVE IT. IT WAS FURTHER REPORTED THAT THE CATHETER WHICH WAS STUCK INSIDE THE PATIENT'S BODY WAS REMOVED BY USING A BALLOON TO PUSH THE CATHETER TO THE SIDE OF THE SHEATH TO TRAP IT TO THE WALL. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20973791 ↗MalfunctionJul 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT AN U420024RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE DETACHMENT INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCE. THE AGE, WEIGHT, AND SEX WERE NOT REPORTED FOR THE PATIENT INVOLVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8796519 ↗
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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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