Ultraverse® 035 PTA Dilatation Catheter U357584Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 8.0mm x 40mm balloon, 75cm shaft · Class 2
All models of Ultraverse 035 PTA Dilatation Catheter (92)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Ultraverse 035 balloon catheter is used to open narrowed leg arteries during angioplasty. Most of the 31 reports describe the balloon bursting during inflation, and parts coming apart, along with difficulty retracting or inserting it. Four reports involve injuries and no deaths are described. 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
- 31
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00801741093951), received between Oct 24, 2016 and Apr 20, 2026 — classified as 4 injuries, 27 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. 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 Rupture21
- Detachment of Device or Device Component11
- Retraction Problem5
- Leak/Splash3
- Break2
- Device Dislodged or Dislocated2
- Difficult to Insert2
- Difficult to Remove2
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient9
- Injury2
- No Known Impact Or Consequence To Patient2
- No Patient Involvement2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2026Deflation Problem; Difficult to Insert; Device-Device Incompatibility
ON (B)(6) 2026, THE PATIENT WAS PREPPED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING AN ULTRAVERSE 035 BALLOON CATHETER. PRIOR TO THE PROCEDURE, THE BALLOON CATHETER WAS REPORTEDLY UNABLE TO BE INSERTED. FURTHER, DEFLATION PROBLEM WAS IDENTIFIED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24921679 ↗MalfunctionSep 24, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE 035 PTA BALLOON TO THE CALCIFIED LESION IN THE LEFT EIA USING A CROSSOVER APPROACH. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON ALLEGEDLY RUPTURED WHEN EXPANDED AT NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23130234 ↗MalfunctionMar 19, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE COMMON ILIAC ARTERY, THE PTA BALLOON CATHETER ALLEGEDLY RUPTURED AT 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 21644454 ↗MalfunctionOct 13, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED COMMON ILIAC ARTERY LESION VIA THE RETROGRADE APPROACH, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT AROUND 4 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON WAS SUCCESSFULLY REMOVED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20436517 ↗MalfunctionJul 29, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC ARTERY STENOSIS VIA AN IPSILATERAL RETROGRADE APPROACH, THE PTA BALLOON RUPTURE HAD ALLEGEDLY OCCURRED BEFORE THE NOMINAL PRESSURE REACHED 6 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19858104 ↗MalfunctionJan 17, 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 18524150 ↗MalfunctionSep 6, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED AND STENOSIS TARGET LESION IN THE ILIAC ARTERY, 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 17688134 ↗MalfunctionJul 4, 2023Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY GOT STUCK WITH THE STENT AND WAS UNABLE TO CROSS THE BENT SITE OF THE STENT. 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 17253597 ↗MalfunctionJan 19, 2023Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT DURING THE RECANALIZATION PROCEDURE THROUGH A TRANSSPLENIC APPROACH AT THE LEVEL OF A SPLENIC VEIN, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO BE REMOVED FROM THE INTRODUCER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16201669 ↗MalfunctionNov 25, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN IN HALF. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15864664 ↗MalfunctionSep 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE CONNECTION PART OF THE BALLOON AND THE SHAFT WAS ALLEGEDLY FOUND TO BE PEELED OFF. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15377869 ↗MalfunctionMay 27, 2022Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE COMMON ILIAC ARTERY VIA AN IPSILATERAL RETROGRADE APPROACH, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO CROSS THE LESION. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY SEEMED LIKE BEING STUCK WITH THE DISTAL PART OF THE STENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14520587 ↗MalfunctionApr 12, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. 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 14081099 ↗MalfunctionOct 28, 2021Material 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 ALLEGEDLY RUPTURED AT 18 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY DETACHED AND THE DETACHED PIECE OF BALLOON WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12711482 ↗InjuryJun 15, 2021Difficult 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 CATHETER ALLEGEDLY SEPARATED AND GOT RETAINED IN THE PATIENT'S LEFT ILIAC. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY RUPTURED AND HAD DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE INTRODUCER SHEATH. REPORTEDLY, THE DEVICE WAS ATTEMPTED TO BE SNARED FROM RIGHT ACCESS BUT UNSUCCESSFUL, THEREFORE, ALTERNATIVE ACCESS WAS OBTAINED. HOWEVER, THE DEVICE WAS UNABLE TO BE REMOVED AFTER SEVERAL ATTEMPTS. THE CURRENT STATUS OF THE PATIENT IS WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11997772 ↗MalfunctionFeb 17, 2021Retraction Problem; Material Rupture; Material Separation; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH LEFT FOREARM, THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11336777 ↗MalfunctionOct 26, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U357584 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THIS MALFUNCTION INVOLVED TWO PATIENTS WITH NO CONSEQUENCES. THE AGE, SEX AND WEIGHT OF THE TWO PATIENTS WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10738104 ↗InjurySep 4, 2020No Display/Image; Device Dislodged or Dislocated; No Display/Image; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON MARKER ALLEGEDLY PLACED ON CATHETER. THE PATIENT STATUS WAS UNKNOWN.
Patient problems: Injury
MAUDE report 10493541 ↗MalfunctionJul 21, 2020Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL U357584 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND DETACHMENT OF DEVICE. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10305164 ↗MalfunctionApr 17, 2020Retraction Problem; Material Rupture; Detachment of Device or Device Component; Retraction Problem; Material Rupture; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U357584 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE, RETRACTION PROBLEM, AND DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE (B)(6) FEMALE PATIENT WEIGHED (B)(6).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9975067 ↗MalfunctionApr 15, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U357584 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE AGE, WEIGHT, AND GENDER OF THE PATIENT WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9964571 ↗MalfunctionApr 15, 2020Retraction Problem; Material Rupture; Retraction Problem; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL U357584 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND RETRACTION PROBLEM. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9964556 ↗MalfunctionFeb 5, 2020Material Rupture
BALLOON RUPTURED UPON INFLATION AND WAS RETRIEVED DURING PERCUTANEOUS ANGIOPLASTY OF LEFT CEPHALIC OUTFLOW VEIN IN THE UPPER ARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9700571 ↗MalfunctionJan 16, 2020Leak/Splash; Material Rupture; Material Split, Cut or Torn; Leak/Splash; Material Rupture; Material Split, Cut or Torn
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE MALFUNCTION INDICATED THAT MODEL U357584 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 9597966 ↗MalfunctionOct 16, 2019Difficult to Insert; Retraction Problem; Difficult to Insert; Retraction Problem
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U357584. PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED RETRACTION PROBLEM AND DIFFICULT TO INSERT. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9199603 ↗
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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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