Ultraverse® RX U4150330RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 3 mm x 300 mm, 150 cm Catheter · Class 2
All models of Ultraverse RX (56)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741057045), received between Nov 13, 2018 and Apr 16, 2025 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (5 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
- Material Rupture5
- Break1
- Detachment of Device or Device Component1
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient2
- Rupture1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN A SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY, THE ULTRAVERSE RX PTA BALLOON WAS ALLEGEDLY RUPTURED AT 6 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21847583 ↗MalfunctionJul 23, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19811973 ↗MalfunctionFeb 27, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN A HIGHLY CALCIFIED LESION VIA IPSILATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18786918 ↗MalfunctionJul 6, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION, THE PTA BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14931665 ↗InjuryJul 1, 2021Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE SHAFT OF THE CATHETER WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE VESSEL ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THE PATIENT CURRENT STATUS WAS UNKNOWN.
Patient problems: Rupture
MAUDE report 12098298 ↗MalfunctionJul 21, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL U4150330RX PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THE INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. OF THE TWO MALFUNCTIONS, BOTH INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. THE (B)(6) YEAR OLD MALE PATIENT WEIGHT WAS NOT PROVIDED. THE AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR ANOTHER PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10305959 ↗MalfunctionNov 13, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT SFA AND POPLITEAL ARTERY, THE PTA BALLOON CATHETER SHAFT ALLEGEDLY BROKE AFTER THE FIRST INFLATION ATTEMPT. THERE WAS NO REPORTED RETRACTION ISSUE THROUGH THE 6FR SHEATH. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8066335 ↗
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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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