Ultraverse® RX U4150520RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 5 mm x 200 mm, 150 cm Catheter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741057977), received between Mar 9, 2017 and Jul 23, 2025 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (8 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture8
- Material Deformation3
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2025Material Rupture; Material Deformation; Material Rupture; Material Deformation
A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS RUPTURED BELOW THE RATED BURST PRESSURE, AND IT WAS AS BUCKLED WHEN REMOVING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22573689 ↗MalfunctionMay 12, 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 BURST AT 8 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON WAS UP FOR 20 SECONDS PRIOR TO BURST. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22000048 ↗MalfunctionMay 12, 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 BURST AT 12 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON WAS UP FOR 30 SECONDS PRIOR TO BURST. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22000046 ↗MalfunctionNov 4, 2024Material 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 20596429 ↗MalfunctionMar 28, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, 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 18993810 ↗MalfunctionApr 9, 2021Material Rupture; Material Deformation; Material Rupture; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE PTA BALLOON ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY RUPTURED DURING INFLATING AT RATED BURST PRESSURE. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11641772 ↗MalfunctionJan 15, 2020Material Rupture; Material Deformation; Material Rupture; Material Deformation
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150520RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9592373 ↗MalfunctionJan 15, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150520RX. PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCE MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9591861 ↗MalfunctionMar 9, 2017Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE IN A SUPERFICIAL FEMORAL ARTERY BY AN IPSILATERAL APPROACH THE SHAFT OF THE PTA CATHETER ALLEGEDLY BROKE ON THE THIRD ATTEMPT TO INFLATE IN THE LESION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6393283 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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