Ultraverse® RX U415024RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 2 mm x 40 mm, 150 cm Catheter · Class 2
Quick summary
This Bard Ultraverse RX balloon catheter is used to open narrowed peripheral arteries during angioplasty. The 30 reports mostly describe the balloon rupturing during the procedure, sometimes below normal pressure, along with the catheter tip or shaft detaching, kinking, or breaking off and having to be removed. Two reports involve injuries and no deaths are reported. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00801741056147), received between Oct 13, 2016 and Aug 10, 2026 — classified as 2 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (21 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 Rupture21
- Detachment of Device or Device Component6
- Failure to Advance4
- Difficult to Remove3
- Material Deformation3
- Break2
- Retraction Problem2
- Deflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 10, 2026Material Rupture
On (b)(6), 2026, a patient underwent a percutaneous transluminal angioplasty procedure using the Ultraverse RX balloon catheter. During the procedure, the balloon catheter 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 50190754 ↗MalfunctionFeb 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. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24363098 ↗MalfunctionJan 19, 2026Material 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. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24107139 ↗MalfunctionOct 1, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE RX PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY PINHOLE RUPTURED BELOW NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23189422 ↗MalfunctionSep 24, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT WAS UNDERGOING AN ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23130511 ↗MalfunctionJul 29, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX PTA BALLOON CATHETER TO TREAT THE SEVERELY CALCIFIED LESION. DURING THE PROCEDURE, THE BALLOON CATHETER COULD NOT PASS THROUGH, AND THE SHAFT BECAME KINKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22640934 ↗MalfunctionMay 23, 2025Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component
ON (B)(6) 2025, DURING ANTERIOR TIBIAL ARTERY EXPANSION IN THE IPSILATERAL SUPERFICIAL FEMORAL ARTERY AND BELOW KNEE LESIONS, 2X40 MM BECAME CAUGHT IN THE CALCIFICATION OF THE SUPERFICIAL FEMORAL ARTERY, PREVENTING THE BALLOON FROM REACHING THE LESION. THE CATHETER FRACTURED AND FELL OUT A FEW HOURS AFTER PLACEMENT. THE FRACTURED BALLOON WAS REMOVED WHILE EXPANDING WITH SHIDEN HP 1.5X20 MM, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22077377 ↗MalfunctionMar 26, 2025Material 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 21694658 ↗MalfunctionDec 14, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE HIGHLY CALCIFIED SUPERFICIAL FEMORAL ARTERY, 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 20932372 ↗MalfunctionOct 13, 2024Deflation Problem; Failure to Advance; Deflation Problem; Failure to Advance
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DID NOT PASS THROUGH THE LESION. IT WAS FURTHER REPORTED THAT THE PTA BALLOON ALLEGEDLY HAD DEFLATION PROBLEM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20436531 ↗MalfunctionSep 12, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED DUE TO THE SEVERE CALCIFICATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20205474 ↗MalfunctionApr 2, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN HIGHLY CALCIFIED BELOW KNEE LESION IN THE IPSILATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 5 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19021575 ↗MalfunctionMar 19, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED DURING THE SECOND DILATION. IT WAS FURTHER REPORTED THAT ALLEGEDLY THERE WAS DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE INTRODUCER SHEATH FOLLOWING THE BALLOON RUPTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18929002 ↗MalfunctionDec 19, 2023Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED DURING EXPANSION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18354102 ↗MalfunctionOct 3, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, UPON OPENING THE PACKAGE, THE SHAFT OF THE PTA BALLOON DILATATION CATHETER WAS ALLEGEDLY FOUND TO BE KINKED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17858911 ↗InjuryAug 23, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE TIBIAL VESSEL VIA GROIN ACCESS, THE PTA BALLOON DILATATION CATHETER ALLEGEDLY BROKE OFF IN THE PATIENT WHEN ATTEMPTED TO REMOVE THE BALLOON CATHETER FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE CATHETER WAS BROKEN INTO TWO SEGMENTS AND IT WAS DIFFICULT TO REMOVE FROM THE PATIENT . PATIENT WAS TAKEN TO SURGERY TO COMPLETE THE PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17600757 ↗MalfunctionMar 7, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6 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 16495793 ↗MalfunctionDec 5, 2022Failure to Advance; Detachment of Device or Device Component; Device-Device Incompatibility; Failure to Advance; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE GUIDEWIRE ALLEGEDLY COULD NOT PASS THROUGH THE BALLOON. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY GOT DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15913595 ↗MalfunctionSep 13, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15409060 ↗MalfunctionSep 2, 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 15346849 ↗MalfunctionAug 29, 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 15309180 ↗MalfunctionAug 2, 2021Material Rupture; Material Deformation; Material Rupture; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A HIGHLY CALCIFIED TARGET LESION IN THE ANTERIOR TIBIAL ARTERY VIA IPSILATERAL ANTEGRADE APPROACH USING 4.5FR SHEATH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 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 12257763 ↗MalfunctionJun 15, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION IN THE LEFT FIBULA ARTERY VIA IPSILATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10 ATM ON THE FIRST INFLATION ATTEMPT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11997827 ↗MalfunctionMay 6, 2021Material 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 11782907 ↗InjuryMar 5, 2021Break; Entrapment of Device; Detachment of Device or Device Component; Break; Entrapment of Device; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF HIGHLY CALCIFIED LESION IN THE LEFT EXTERNAL ILIAC ARTERY, THE PTA BALLOON ALLEGEDLY STUCK AND SHAFT OF THE CATHETER WAS ALLEGEDLY BROKEN. REPORTEDLY A PIECE OF THE BROKEN CATHETER WAS REMAINED IN THE PATIENTS BODY WHEN THE CATHETER WAS REMOVED FROM THE PATIENT. THE LESION WAS SEVERELY CALCIFIED AND AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE DEBRIS. PATIENT CURRENT STATUS IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11419370 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.