Ultraverse® RX U415064RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 6 mm x 40 mm, 150 cm Catheter · Class 2
All models of Ultraverse RX (56)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Ultraverse RX PTA balloon catheter is used to open narrowed leg arteries during angioplasty. The 27 reports mostly describe the balloon bursting during the procedure, often against heavily calcified arteries, plus a few cases of the shaft kinking or the balloon failing to advance. No deaths and no injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741058066), received between Oct 24, 2016 and Apr 17, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (19 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture19
- Failure to Advance4
- Material Deformation4
- Break2
- Deflation Problem2
- Detachment of Device or Device Component2
- Difficult to Insert2
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Consequences Or Impact To Patient7
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2026Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER 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 24908634 ↗MalfunctionDec 30, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED DURING POBA OF A HIGHLY CALCIFIED SFA ORIGIN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23919877 ↗MalfunctionOct 22, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE RX BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED DUE TO SEVERELY CALCIFIED LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23355707 ↗MalfunctionSep 24, 2025Material Deformation; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH USING THE ULTRAVERSE RX PTA BALLOON. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SHAFT ALLEGEDLY KINKED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23130015 ↗MalfunctionSep 9, 2025Material Rupture; Material Rupture
A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX PTA BALLOON CATHETER, FOR AN UNKNOWN MEDICAL CONDITION. DURING THE PROCEDURE THE BALLOON WAS ALLEGEDLY RUPTURED AT 7 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23001662 ↗MalfunctionMar 25, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 4 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21685149 ↗MalfunctionAug 15, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED STENOSIS, 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 19990278 ↗MalfunctionAug 9, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE HIGHLY CALCIFIED SUPERFICIAL FEMORAL ARTERY LESION, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19946660 ↗MalfunctionJul 23, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED SUPERFICIAL FEMORAL ARTERY VIA THE CONTRALATERAL APPROACH, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19812693 ↗MalfunctionJun 12, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED IN NOMINAL WHEN DILATED IN CALCIFIED LESIONS. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19517433 ↗MalfunctionDec 8, 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 18289489 ↗MalfunctionNov 23, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18200026 ↗MalfunctionOct 5, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT THE FIRST POST-DILATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17874799 ↗MalfunctionApr 25, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE COMMON FEMORAL ARTERY VIA A CONTRALATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16806031 ↗MalfunctionJun 20, 2022Material 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 14741534 ↗MalfunctionJan 6, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED UNDER NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13173672 ↗MalfunctionApr 26, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC ARTERY VIA CONTRALATERAL APPROACH, THE CATHETER SHAFT WAS ALLEGEDLY KINKED ON THE SECOND INFLATION ATTEMPT. 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 11722659 ↗MalfunctionApr 16, 2021Material 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 11676604 ↗MalfunctionDec 2, 2020Break; Failure to Advance; Break; Failure to Advance
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF HIGHLY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY VIA IPISRATERAL APPROACH, THE CATHETER WAS UNABLE TO CROSS THE LESION. IT WAS FURTHER REPORTED THAT THE CATHETER SHAFT ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10933017 ↗MalfunctionOct 26, 2020Break; 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 U415064RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE OR DEVICE COMPONENT. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. AGE, GENDER AND WEIGHT WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10734702 ↗MalfunctionOct 13, 2020Deflation Problem; Difficult to Insert; Deflation Problem; Difficult to Insert
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD DIFFICULTY BEING DEFLATED AND FAILED TO BE INSERTED AT THE SECOND ATTEMPT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10670767 ↗MalfunctionJul 22, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL U415064RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10308243 ↗MalfunctionJul 22, 2020Deflation Problem; Difficult to Insert; Failure to Advance; Material Deformation; Deflation Problem; Difficult to Insert; Failure to Advance; Material Deformation
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL U415064RX PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION PROBLEM, FAILURE TO ADVANCE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE PATIENTS¿ AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10308138 ↗MalfunctionApr 20, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U415064RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE.THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE MALFUNCTIONS INVOLVED TWO PATIENTS WITH NO CONSEQUENCES. THE WEIGHT OF ONE (B)(6) YEAR OLD FEMALE IS (B)(6) KGS AND ANOTHER PATIENT'S INFORMATION WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9977304 ↗MalfunctionApr 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 U415064RX PTA BALLOON DILATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION AND FAILURE TO ADVANCE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9963235 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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