Ultraverse® RX U41501H12RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 1.5 mm x 120 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
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741055997), received between Jan 15, 2020 and Jan 12, 2026 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (15 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 Rupture15
- Failure to Advance5
- Material Deformation4
- Break2
- Device-Device Incompatibility2
- Difficult to Remove2
- Deflation Problem1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2026Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE THROUGH THE ULTRAVERSE RX BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER WAS ALLEGEDLY UNABLE TO CROSS THROUGH THE LESION AND HAD DIFFICULTY REMOVING THE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WERE NO REPORTED PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24033678 ↗MalfunctionSep 25, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX 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 23142773 ↗MalfunctionMay 26, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, PRIOR TO AN ANGIOPLASTY PROCEDURE VIA IPSILATERAL ANTEGRADE BK IN A CASE OF ATA OBSTRUCTION WITH SEVERE CALCIFICATION USING AN ULTRAVERSE RX BALLOON, RUPTURE OCCURRED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22083145 ↗MalfunctionMay 12, 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 22002493 ↗MalfunctionMay 9, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX PTA BALLOON CATHETER. DURING THE PROCEDURE THE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21993834 ↗MalfunctionMar 7, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED UNDER NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21543691 ↗MalfunctionFeb 25, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 8 ATM WHEN LESION EXPANDS. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21455930 ↗MalfunctionNov 5, 2024Deflation Problem; Failure to Advance; Deflation Problem; Failure to Advance
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED LESION, THE PTA BALLOON CATHETER ALLEGEDLY DID NOT PASS THROUGH THE LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20606756 ↗MalfunctionAug 12, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE BELOW KNEE DISTAL ANTERIOR TIBIAL ARTERY TO DORSAL FOOT VIA AN IPSILATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6 ATM. IT WAS FURTHER REPORTED THAT THE RUPTURED BALLOON WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19969085 ↗MalfunctionJul 8, 2024Break; Break
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON SHAFT ALLEGEDLY BROKE AND ENDS UP PASSING THROUGH UNSUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19688808 ↗MalfunctionMay 28, 2024Material 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 19403241 ↗MalfunctionMay 27, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19400461 ↗MalfunctionMay 8, 2024Break; Failure to Advance; Break; Failure to Advance
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA THE CONTRALATERAL FEMORAL APPROACH, THE DEVICE ALLEGEDLY STOPPED ADVANCING AT THE AORTIC BIFURCATION. IT WAS FURTHER REPORTED THAT WHEN REMOVED, THE BALLOON SHAFT WAS ALLEGEDLY FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19268435 ↗MalfunctionJan 9, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18472937 ↗MalfunctionNov 7, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA AN IPSILATERAL ANTEGRADE APPROACH, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 3 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18082668 ↗MalfunctionApr 8, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A HIGHLY CALCIFIED TARGET LESION BELOW THE KNEE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 5 ATM. 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 14050412 ↗MalfunctionMar 31, 2022Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A TARGET LESION BELOW THE KNEE VIA AN IPSILATERAL ANTEGRADE APPROACH, THERE WAS STRONG RESISTANCE FELT AND THE DEVICE WAS ALLEGEDLY UNABLE TO BE REMOVED AFTER INFLATION. THE BALLOON AND THE GUIDEWIRE WERE REMOVED TOGETHER AS ONE UNIT. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS ALLEGEDLY FOUND DETACHED AND THE DETACHED SEGMENT WAS IN THE GUIDEWIRE LUMEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13963822 ↗MalfunctionMar 15, 2021Material Rupture; Material Deformation; Material Rupture; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A TARGET LESION BELOW THE KNEE, THE PTA BALLOON ALLEGEDLY RUPTURED. REPORTEDLY, THE DEVICE WAS PUNCTURED AT AN ACUTE ANGLE SINCE THE PATIENT WAS OBESE AND THE SHEATH HAD BEEN KINKED BEFORE INFLATION. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11483430 ↗MalfunctionFeb 23, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY, THE DEVICE ALLEGEDLY FAILED TO ADVANCE. THERE WAS RESISTANCE FELT DURING ADVANCING AND THE CATHETER SHAFT OF THE PTA BALLOON WAS FOUND KINKED. 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 11364615 ↗MalfunctionJul 22, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES FOUR MALFUNCTIONS. A REVIEW OF THE MALFUNCTION INDICATED THAT MODEL U41501H12RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL MALFUNCTIONS INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. OF THE FOUR PATIENTS, ONE WAS A (B)(6) YEAR OLD MALE AND WEIGHT WAS NOT PROVIDED. ALL OTHER PATIENTS INFORMATION WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10310402 ↗MalfunctionJul 22, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41501H12RX ULTRA VERSE RX PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION AND FAILURE TO ADVANCE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. AGE, WEIGHT, AND GENDER OF THE PATIENT WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10310314 ↗MalfunctionJan 15, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41501H12RX 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. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9591797 ↗
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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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