Ultraverse® RX U415074RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 7 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
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741058103), received between Mar 20, 2017 and Jan 9, 2026 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (13 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 Rupture13
- Detachment of Device or Device Component2
- Difficult to Remove2
- Failure to Advance2
- Material Deformation2
- Break1
- Device Contamination with Chemical or Other Material1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2026Failure to Advance; Device-Device Incompatibility; Device Contamination with Chemical or Other Material
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX BALLOON CATHETER VIA IPSILATERAL RETROGRADE APPROACH. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY UNABLE TO ADVANCE AND FOREIGN OBJECT WERE OBSERVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24017219 ↗MalfunctionSep 8, 2025Material Rupture; Material Rupture
A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX PTA BALLOON CATHETER. DURING THE PROCEDURE THE BALLOON WAS 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 22990458 ↗MalfunctionAug 14, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, THE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE OF CALCIFIED TARGET LESION IN THE ILIAC VEIN, USING THE ULTRAVERSE RX PTA BALLOON WHICH ALLEGEDLY RUPTURED AT 6 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22804007 ↗MalfunctionAug 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 RUPTURED AT 5 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22784342 ↗MalfunctionDec 14, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6 ATM DURING THE SECOND EXPANSION. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE INTRODUCER SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20932335 ↗MalfunctionDec 3, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FOR CONTRALATERAL SUPERFICIAL FEMORAL ARTERY, THE GUIDEWIRE LUMEN OF THE CATHETER WAS ALLEGEDLY CRUSHED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY FAILED TO PASS THROUGH THE LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20831371 ↗MalfunctionOct 22, 2024Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA CONTRALATERAL APPROACH, THE BALLOON ALLEGEDLY KINKED DURING DELIVERY. IT WAS FURTHER REPORTED THAT THE CATHETER WAS FOUND TO BE ALLEGEDLY BROKEN. REPORTEDLY, THE SAME PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20506481 ↗MalfunctionJul 23, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED COMMON FEMORAL ARTERY, THE BALLOON WAS RUPTURED. THE PROCEDURE WAS BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19804609 ↗MalfunctionJul 16, 2024Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY DETACHED AND THE BALLOON WAS ALLEGEDLY DIFFICULT TO BE RETRACTED FROM THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19748619 ↗MalfunctionFeb 20, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN TREATING A MILDLY CALCIFIED STENOSIS OF COMMON ILIAC ARTERY TO EXTERNAL ILIAC ARTERY BY IPSILATERAL RETROGRADE APPROACH, THE PTA BALLOON 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 18738809 ↗MalfunctionFeb 12, 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 18682994 ↗MalfunctionNov 21, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18179657 ↗MalfunctionNov 14, 2023Material 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 18128992 ↗MalfunctionJun 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA AN IPSILATERAL ANTEGRADE APPROACH, A LARGE MISALIGNMENT WAS ALLEGEDLY CONFIRMED BETWEEN THE BALLOON LENGTH AND THE RADIOPAQUE MARKER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17224297 ↗MalfunctionJul 22, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U415074RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. THREE MALFUNCTIONS WERE INVOLVED WITH NO PATIENT CONSEQUENCES. ONE PATIENT IS AN 80 YEAR OLD FEMALE, WHOSE WEIGHT WAS NOT PROVIDED. AGE, GENDER AND WEIGHT WERE NOT PROVIDED FOR THE REMAINING TWO PATIENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10309414 ↗MalfunctionJan 14, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U415074RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE MATERIAL RUPTURE, ONE INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS A 70 YEAR OLD MALE AND THEIR WEIGHT INFORMATION WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9587136 ↗MalfunctionAug 30, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT EXTERNAL ILIAC ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7834777 ↗MalfunctionMar 20, 2017Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT UPON COMPLETION OF AN ANGIOPLASTY PROCEDURE IN THE ILIAC ARTERY, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO BE REMOVED FROM THE SHEATH. REPORTEDLY, DURING RETRACTION THROUGH THE SHEATH THE DISTAL PORTION OF THE BALLOON CATHETER DETACHED INSIDE THE PATIENT. THE HEALTH CARE PROVIDER REMOVED THE DETACHED SEGMENT WITH A SNARE DEVICE AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6419651 ↗
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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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