Ultraverse® RX U4150510RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 5 mm x 100 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
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741057885), received between Jun 8, 2017 and Sep 10, 2025 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (12 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 Rupture12
- Material Deformation3
- Deflation Problem1
- Entrapment of Device1
- Failure to Advance1
- Inflation Problem1
- Leak/Splash1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH USING THE ULTRAVERSE RX PTA BALLOON CATHETER. DURING THE PROCEDURE THE BALLOON ALLEGEDLY FAILED TO REACH THE LESION. IT WAS FURTHER REPORTED THAT WHEN THE CATHETER WAS REMOVED FROM THE BODY, IT WAS FOUND THAT THE SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23013118 ↗MalfunctionApr 29, 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 21924990 ↗MalfunctionApr 1, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21737685 ↗MalfunctionMar 11, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21570998 ↗MalfunctionJan 9, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10 ATM WHEN LESION EXPANDS. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21111305 ↗MalfunctionAug 25, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY VIA AN IPSILATERAL APPROACH, THE PTA BALLOON WAS 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 20060817 ↗MalfunctionJul 10, 2024Inflation Problem; Material Deformation; Material Twisted/Bent; Inflation Problem; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY TWISTED AND DID NOT FULLY EXPAND. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19708314 ↗MalfunctionFeb 5, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED IMMEDIATELY AFTER EXPANSION. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18639212 ↗MalfunctionJan 2, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED SUPERFICIAL FEMORAL ARTERY LESION VIA AN IPSILATERAL APPROACH, 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 18424804 ↗MalfunctionAug 4, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION IN THE POPLITEAL 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 15162994 ↗MalfunctionAug 27, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, 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 12375969 ↗MalfunctionMar 15, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER SHAFT WAS ALLEGEDLY KINKED DURING INSERTION. 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 11483580 ↗MalfunctionOct 27, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150510RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE MALE PATIENT AGE AND WEIGHT WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10738891 ↗MalfunctionApr 15, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF REPORTED INFORMATION INDICATES THAT MODEL U4150510RX, PTA BALLOON DILATATION CATHETER, ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A FEMALE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S WEIGHT AND AGE WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9963415 ↗MalfunctionJan 15, 2020Entrapment of Device; Material Rupture; Entrapment of Device; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL U4150510RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND ENTRAPMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. THE (B)(6) YEAR OLD MALE WEIGHED (B)(6) KGS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9593191 ↗MalfunctionJun 8, 2017Deflation Problem; Leak/Splash; Deflation Problem; Leak/Splash
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE, NEGATIVE PRESSURE WAS APPLIED TO REMOVE THE DEVICE FROM THE PATIENT AND ALLEGEDLY BLOOD WAS OBSERVED LEAKING FROM THE SHAFT . THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6628837 ↗
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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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