Ultraverse® RX U4150530RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 5 mm x 300 mm, 150 cm Catheter · Class 2
All models of Ultraverse RX (56)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741058035), received between Nov 16, 2017 and Sep 2, 2025 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (13 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture13
- Failure to Advance3
- Material Deformation3
- Break2
- Detachment of Device or Device Component2
- Deflation Problem1
- Difficult to Remove1
- Kinked1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Consequences Or Impact To Patient9
- No Patient Involvement1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERGONE AN ANGIOPLASTY FOR A CHRONIC TOTAL OCCLUSION (CTO) LESION IN THE SUPERFICIAL FEMORAL ARTERY USING AN IPSILATERAL APPROACH. IT WAS REPORTED THAT THE PTA BALLOON RUPTURED PRIOR TO THE PRESSURE BEING RAISED TO THE NOMINAL LEVEL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF AN ALTERNATIVE DEVICE. THERE WERE NO INJURIES REPORTED FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22930975 ↗MalfunctionMay 2, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19230175 ↗MalfunctionApr 27, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16822620 ↗MalfunctionApr 6, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY VIA AN IPSILATERAL ANTEGRADE APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED UNDER NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16687848 ↗MalfunctionJan 20, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA AN IPSILATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6 ATM. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16213349 ↗MalfunctionSep 1, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT BALLOON ALLEGEDLY DIFFICULT TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15333794 ↗MalfunctionMay 18, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, 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 11840411 ↗MalfunctionDec 29, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A HIGHLY CALCIFIED TAGET LESION, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO COMPLETE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11086533 ↗MalfunctionOct 30, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A LESION IN THE SUPERFICIAL FEMORAL ARTERY, 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 10760622 ↗MalfunctionOct 27, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES FOUR MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150530RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A BALLOON RUPTURE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. ALL MALFUNCTIONS INVOLVED A PATIENT WITH NO REPORTED PATIENT CONSEQUENCE. THE MALFUNCTION INVOLVES TWO FEMALES AND ONE MALE ALL OTHER PATIENT INFORMATION WAS NOT PROVIDED FOR ANY OF THE PATIENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10738834 ↗MalfunctionOct 12, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A HIGHLY CALCIFIED TARGET LEGION IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRA LATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10662363 ↗MalfunctionJul 22, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL U4150530RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THE INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. ALL THE THREE MALFUNCTIONS INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. THE AGE, WEIGHT AND GENDER WERE NOT PROVIDED FOR ALL THE THREE PATIENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10311095 ↗MalfunctionJul 21, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150530RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION AND FAILURE TO ADVANCE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, SEX AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10300281 ↗MalfunctionApr 15, 2020Material Deformation; Material Deformation
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150530RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS A 78 YEAR OLD MALE; WEIGHT WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9963339 ↗MalfunctionApr 15, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150530RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL THREE EVENTS HAD NO REPORTED PATIENT INJURY. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9963335 ↗MalfunctionJan 15, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150530RX ULTRASVERSE RX PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION (KINK) AND FAILURE TO ADVANCE ISSUES. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE REPORTED MALFUNCTION, ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCE OR IMPACT. THE PATIENT WAS A MALE, (B)(6) YEARS OF AGE, HOWEVER, THE WEIGHT WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9591278 ↗MalfunctionOct 21, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150530RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ONE MALFUNCTION DID NOT INVOLVE A PATIENT, THEREFORE, NO PATIENT INFORMATION WAS NEEDED OR PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 9215977 ↗MalfunctionOct 14, 2019Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150530RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE MALFUNCTION, A PATIENT WAS INVOLVED WITH NO REPORTED PATIENT CONSEQUENCES. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9186468 ↗MalfunctionJul 16, 2019Break; Failure to Advance; Break; Failure to Advance
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150530RX PTA BALLOON DILATATION CATHETER ALLEGEDLY FAILED TO ADVANCE AND BROKE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT AGE AND WEIGHT WERE NOT PROVIDED. THE PATIENT WAS REPORTED TO BE MALE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8796520 ↗MalfunctionNov 16, 2017Kinked; Detachment of Device or Device Component; Kinked; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A TREATMENT FOR A LESION, THE SHAFT OF THE PTA BALLOON CATHETER ALLEGEDLY KINKED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7038518 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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