Ultraverse® RX U415044RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 4 mm x 40 mm, 150 cm Catheter · Class 2
Quick summary
This Bard Ultraverse RX balloon catheter is used to open narrowed arteries in the limbs during angioplasty. The 38 reports mostly describe the balloon bursting during the procedure, along with kinked or misshapen shafts that would not pass through the sheath, and pieces detaching. Most involved no harm to the patient; one injury was reported and no deaths. There are no recalls naming 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
- 38
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00801741057465), received between Mar 7, 2017 and Apr 13, 2026 — classified as 1 injury, 37 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (25 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture25
- Material Deformation8
- Failure to Advance6
- Detachment of Device or Device Component4
- Device-Device Incompatibility2
- Activation Problem1
- Break1
- Deflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Consequences Or Impact To Patient9
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 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. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24854711 ↗MalfunctionApr 3, 2026Difficult to Insert; Device-Device Incompatibility; Material Deformation
ON (B)(6) 2026, A PATIENT WAS PREPPED FOR AN ANGIOPLASTY PROCEDURE VIA IPSILATERAL ANTEGRADE APPROACH USING THE ULTRAVERSE RX. PRIOR TO THE PROCEDURE, THE SHAFT ALLEGEDLY KINKED AND WOULD NOT PASS THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781198 ↗MalfunctionMar 26, 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. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24695494 ↗MalfunctionDec 22, 2025Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture
ON (B)(6) 2025, 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 RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23861974 ↗MalfunctionOct 15, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE IN COMMON FEMORAL ARTERY USING THE ULTRAVERSE RX PTA BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE 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 23298030 ↗MalfunctionAug 27, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, THE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE RX PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY GOT RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22901732 ↗MalfunctionAug 13, 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. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22791768 ↗MalfunctionAug 12, 2025Material Rupture; Material Rupture
A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING ULTRAVERSE RX DEVICE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 8 ATM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22784353 ↗MalfunctionJul 15, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING AN ULTRAVERSE RX. DURING THE PROCEDURE, THE BALLOON, AFTER PASSING A WIRE THROUGH THE ILIAC LESION. THE GUIDING SHEATH WAS SIGNIFICANTLY BENT AT THE ARCH OF THE AORTA, CAUSING THE SHAFT SECTION TO KINK DURING PRODUCT DELIVERY. DELIVERY TO THE LESION WAS SOMEHOW ACHIEVED, BUT PUSHABILITY WAS INEFFECTIVE AND THE PRODUCT COULD NOT BE PASSED THROUGH THE LESION. SUCCESSFUL DILATION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22504538 ↗MalfunctionFeb 27, 2025Failure to Advance; Device-Device Incompatibility; Material Deformation; Failure to Advance; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER SHAFT OF THE PTA BALLOON ALLEGEDLY HAD A KINK. IT WAS FURTHER REPORTED IT COULD NOT BE INSERTED THROUGH GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21477259 ↗MalfunctionOct 16, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20467828 ↗MalfunctionOct 7, 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 20385105 ↗MalfunctionJun 17, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED SUPERFICIAL FEMORAL ARTERY LESION VIA AN IPSILATERAL APPROACH, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19545334 ↗MalfunctionApr 11, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE HIGHLY CALCIFIED SUPERFICIAL FEMORAL ARTERY VIA THE CONTRALATERAL APPROACH, THE PTA BALLOON RUPTURE ALLEGEDLY OCCURRED DUE TO CALCIFICATION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19086084 ↗MalfunctionApr 1, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CONTRALATERAL APPROACH, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 6 ATM. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19011511 ↗MalfunctionFeb 20, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM DURING LESION EXTENSION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18738820 ↗MalfunctionOct 11, 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 17910678 ↗MalfunctionSep 11, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17717359 ↗MalfunctionDec 9, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO CROSS LESION AND THE SHAFT OF THE CATHETER WAS ALLEGEDLY FOUND TO BE 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 12967830 ↗MalfunctionSep 24, 2021Activation Problem; Activation Problem
IT WAS REPORTED THAT THE SAFETY MECHANISM DID NOT WORK WHEN THE NEEDLE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12526546 ↗MalfunctionMay 31, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE CATHETER SHAFT WAS ALLEGEDLY BROKEN DURING THE SECOND INSERTION. 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 11906236 ↗MalfunctionMar 1, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10 ATM. IT WAS FURTHER REPORTED THAT ANOTHER PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11395179 ↗MalfunctionFeb 10, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF HIGHLY CALCIFIED LESION WITH STENT FRACTURE IN THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11305966 ↗MalfunctionFeb 8, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF CALCIFIED LESION IN THE POPLITEAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11291347 ↗MalfunctionDec 31, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE CATHETER SHAFT OF THE PTA BALLOON WAS ALLEGEDLY KINKED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11099800 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.