Ultraverse® RX U41502H30RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 2.5 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
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741056710), received between Jan 12, 2017 and Mar 19, 2026 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (14 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 Rupture14
- Break2
- Deflation Problem2
- Detachment of Device or Device Component2
- Difficult to Remove2
- Failure to Advance1
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2026Deflation Problem; Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE BY USING THE ULTRAVERSE RX BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY FAILED TO FULLY DEFLATE, AND WHEN REMOVAL WAS ATTEMPTED, THE CATHETER BALLOON WAS RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24635975 ↗MalfunctionOct 16, 2025Break; Difficult to Remove; Failure to Advance; Break; Difficult to Remove; Failure to Advance
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE IN ANTERIOR TIBIAL ARTERY VIA CONTRALATERAL APPROACH USING THE ULTRAVERSE RX PTA BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WAS ALLEGEDLY KINKED AND BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23308456 ↗MalfunctionApr 22, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD A DEFORMATION UPON OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21879221 ↗MalfunctionSep 16, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY, 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 20226463 ↗MalfunctionAug 28, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA IPSILATERAL APPROACH, THE PTA BALLOON ALLEGEDLY LEAKED AT 6 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20093086 ↗MalfunctionJul 2, 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 19654449 ↗MalfunctionJun 20, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED LESION OF ANTERIOR TIBIAL ARTERY, 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 19573857 ↗MalfunctionApr 13, 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 19102582 ↗MalfunctionFeb 23, 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 16425683 ↗MalfunctionAug 11, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A TARGET LESION BELOW THE KNEE, THE PTA BALLOON ALLEGEDLY RUPTURED. 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 15207844 ↗MalfunctionMay 10, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A RE-OCCLUDED LESION BELOW THE KNEE, THE PTA BALLOON ALLEGEDLY HAD A PINHOLE RUPTURE. IT WAS FURTHER REPORTED THAT THROMBIN WAS INJECTED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14345748 ↗MalfunctionApr 5, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE BELOW THE KNEE, THE PTA BALLOON ALLEGEDLY RUPTURED. 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 14012020 ↗MalfunctionFeb 23, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LEGION BELOW THE KNEE, 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 13582757 ↗MalfunctionJun 7, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT ANTERIOR TIBIAL ARTERY, THE PTA BALLOON ALLEGEDLY DETACHED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11944917 ↗MalfunctionDec 22, 2020Difficult to Remove; Detachment of Device or Device Component; Material Twisted/Bent; Difficult to Remove; Detachment of Device or Device Component; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LESION BELOW THE KNEE, THE PTA BALLOON WAS ALLEGEDLY TWISTED. REPORTEDLY, IT WAS DIFFICULT TO REMOVE THE BALLOON AND THE CATHETER SHAFT ALLEGEDLY DETACHED DURING REMOVAL. THE DISTAL CATHETER SEGMENT WAS REMOVED USING GUIDING SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11054088 ↗MalfunctionNov 24, 2020Material 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 10893361 ↗MalfunctionNov 11, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF CALCIFIED LESION BELOW THE KNEE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 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 10820997 ↗MalfunctionJul 22, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41502H30RX PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. OF THE THREE MALFUNCTION, THREE PATIENTS WERE INVOLVED WITH NO PATIENT CONSEQUENCES OR IMPACT. THE PATIENTS INVOLVED WERE ONE (B)(6) YEARS OLD FEMALE, ONE MALE OF UNKNOWN AGE AND THE GENDER OF THE OTHER PATIENT WAS NOT REPORTED. THE WEIGHT OF NONE OF THE PATIENTS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10311163 ↗MalfunctionJan 12, 2017Deflation Problem; Deflation Problem
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY THE PTA BALLOON COULD NOT BE FULLY DEFLATED AFTER THE FIRST INFLATION; HOWEVER THE BALLOON WAS SUCCESSFULLY RETRACTED THROUGH THE SHEATH. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6247827 ↗
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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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