Ultraverse® RX U4150430RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 4 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
- 12
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741057700), received between Jul 24, 2019 and Sep 8, 2025 — classified as 1 injury, 11 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (9 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 Rupture9
- Material Deformation2
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient5
- Vascular Dissection1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2025Break; Material Deformation; Break; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE RX DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SHAFT WAS ALLEGEDLY FOUND TO BE BROKEN AND HAD TO BE REMOVED FROM THE BODY. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22989920 ↗MalfunctionSep 5, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX PTA BALLOON CATHETER. DURING THE PROCEDURE THE BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22978855 ↗MalfunctionJan 16, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED CHRONIC TOTAL OCCLUSION LESION VIA SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT 7 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21166295 ↗MalfunctionFeb 7, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CONTRALATERAL SUPERFICIAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT 5 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18657860 ↗MalfunctionMay 31, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10 ATM ON THE FIRST INFLATION ATTEMPT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14545490 ↗InjuryDec 2, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CHRONIC TOTAL OCCLUSION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED VASCULAR DISSECTION AND AN ADDITIONAL INTERVENTION WAS REQUIRED TO IMPLANT STENT. THE CURRENT PATIENT STATUS IS UNKNOWN.
Patient problems: Vascular Dissection
MAUDE report 12914591 ↗MalfunctionNov 18, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER SHAFT WAS ALLEGEDLY KINKED. 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 10862609 ↗MalfunctionJul 22, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES FOUR MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150430RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. FOUR MALFUNCTIONS WERE INVOLVED WITH NO PATIENT CONSEQUENCES. THE DEVICE WAS USED IN A MALE PATIENT WHOSE WEIGHT AND SEX WAS NOT PROVIDED. AGE, GENDER AND WEIGHT OF THE REMAINING THREE PATIENTS WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10311129 ↗MalfunctionApr 20, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150430RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9979838 ↗MalfunctionApr 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150430RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE (B)(6) MALE PATIENT'S WEIGHT WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9975247 ↗MalfunctionJan 15, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150430RX 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 9593180 ↗MalfunctionJul 24, 2019Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150430RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8823497 ↗
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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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