Ultraverse® RX U4150525RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 5 mm x 250 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
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741058004), received between Apr 4, 2017 and Jul 16, 2024 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (7 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 Rupture7
- Material Deformation2
- Break1
- Detachment of Device or Device Component1
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA CONTRALATERAL SUPERFICIAL FEMORAL ARTERY, THE 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 19748728 ↗MalfunctionJun 25, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED SUPERFICIAL FEMORAL ARTERY LESION VIA THE SAME SIDE APPROACH, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 8 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19605141 ↗MalfunctionAug 8, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER SHAFT OF THE PTA BALLOON ALLEGEDLY KINKED AS THE PHYSICIAN APPLIED FORCE TO ADVANCE THE BALLOON. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15181644 ↗MalfunctionApr 21, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER SHAFT OF THE PTA BALLOON ALLEGEDLY KINKED AS THE PHYSICIAN APPLIED STRONG FORCE AT THE LESION. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14166969 ↗MalfunctionApr 21, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF CALCIFIED LESION, THE PTA BALLOON ALLEGEDLY RUPTURED UNDER NOMINAL PRESSURE. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11698687 ↗MalfunctionDec 15, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT ANOTHER PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11010009 ↗MalfunctionJul 22, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150525RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL THREE MALFUNCTIONS INVOLVED A PATIENT WITH NO REPORTED PATIENT CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10311424 ↗MalfunctionApr 17, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150525RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9975246 ↗MalfunctionApr 7, 2017Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SFA, THE PTA BALLOON ALLEGEDLY RUPTURED AT 3 ATM ON THE FIRST INFLATION ATTEMPT. 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 6474250 ↗MalfunctionApr 4, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE USING A CONTRALATERAL APPROACH WITH INCREASING DILATING PRESSURE, THE PTA BALLOON CATHETER ALLEGEDLY BROKE WHEN IT WAS ADVANCED ACROSS THE VESSEL WITH FORCE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6457371 ↗
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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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