Ultraverse® RX U4150210RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 2 mm x 100 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
- 14
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741056239), received between Aug 28, 2018 and May 5, 2025 — classified as 1 injury, 13 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (10 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 Rupture10
- Detachment of Device or Device Component2
- Device-Device Incompatibility1
- Failure to Advance1
- Material Deformation1
- Material Separation1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Consequences Or Impact To Patient5
- No Patient Involvement1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 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. IT WAS FURTHER REPORTED THAT THE RUPTURE OCCURRED DUE TO POOR CONTACT WITH THE CALCIFICATION DURING DELIVERY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21959204 ↗MalfunctionApr 15, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY NOMINAL RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21837878 ↗MalfunctionApr 11, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY VALVULOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED BELOW THE NORMAL PRESSURE AND THE LESION WAS POORLY DILATED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21823855 ↗MalfunctionJan 20, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED APPROXIMATELY 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 21191238 ↗MalfunctionSep 18, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, 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 20246601 ↗MalfunctionJul 2, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED BELOW-THE-KNEE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19655948 ↗MalfunctionDec 12, 2021Material Separation; Failure to Advance; Device-Device Incompatibility; Material Separation; Failure to Advance; Device-Device Incompatibility
IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE, THE GUIDEWIRE ALLEGEDLY WAS UNABLE TO INSERT INTO THE GUIDEWIRE LUMEN. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12981973 ↗MalfunctionApr 20, 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 11691547 ↗MalfunctionOct 26, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150210RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ONE REPORTED MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE AGE AND WEIGHT OF THE FEMALE PATIENT WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10738140 ↗MalfunctionJul 22, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150210RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THESE MALFUNCTIONS INVOLVED PATIENTS WITH NO CONSEQUENCES. AGE, WEIGHT, AND GENDER OF THE PATIENT WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10310746 ↗MalfunctionApr 20, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150210RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE THREE MALFUNCTIONS INVOLVED THREE PATIENTS WITH NO PATIENT CONSEQUENCES. THE AGE OF TWO PATIENTS WERE (B)(6). ONE PATIENT WEIGHED (B)(6) KGS. ONE PATIENT WAS REPORTEDLY MALE AND ONE PATIENT WAS REPORTEDLY FEMALE. ALL OTHER PATIENT INFORMATION WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9979837 ↗MalfunctionJan 15, 2020Material Deformation; Material Deformation
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150210RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE MALE PATIENT'S AGE AND WEIGHT WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9594172 ↗MalfunctionJan 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DETACHED FROM THE CATHETER. ANOTHER DEVICE WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8224148 ↗InjuryAug 28, 2018Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A STENOTIC LESION IN THE ARTIFICIAL BLOOD VESSEL BELOW THE RIGHT KNEE, USING AN IPSILATERAL ANTEGRADE APPROACH, THE PTA BALLOON CATHETER SHAFT DETACHED AND REMAINED AT THE LESION SITE. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY RETRACTING THE BALLOON THROUGH THE SHEATH. REPORTEDLY, THE HEATH CARE PROVIDER (HCP) ATTEMPTED TO RETRIEVE THE DETACHED SEGMENT USING A SNARE DEVICE BUT WAS UNSUCCESSFUL. THE HCP DECIDED TO SURGICALLY REMOVE THE DETACHED SEGMENT. THE PROCEDURE WAS CONCLUDED, AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7824380 ↗
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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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