Ultraverse® 035 PTA Dilatation Catheter U3575615Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 6.0mm x 150mm 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
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741093005), received between Nov 20, 2017 and Mar 25, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (3 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 Rupture3
- Retraction Problem3
- Detachment of Device or Device Component2
- Leak/Splash1
- Material Split, Cut or Torn1
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE VIA CONTRALATERAL APPROACH USING THE ULTRAVERSE 035 PTA BALLOON. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24684743 ↗MalfunctionFeb 11, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE HUB OF THE PTA BALLOON ALLEGEDLY HAD A LEAK DURING INFLATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21357495 ↗MalfunctionApr 20, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U3575615 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9979805 ↗MalfunctionAug 20, 2018Retraction Problem; Material Rupture; Retraction Problem; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC ARTERY, USING AN IPSILATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 14ATM ON THE FIRST INFLATION ATTEMPT. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY RETRACTING THE BALLOON THROUGH THE SHEATH AND SUBSEQUENTLY THE BALLOON AND SHEATH WERE REMOVED AS ONE UNIT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7799652 ↗MalfunctionApr 9, 2018Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SFA ,USING AN ANTEGRADE APPROACH, ACCESS WAS GAINED IN THE COMMON FEMORAL ARTERY. REPORTEDLY, THE PTA BALLOON ALLEGEDLY WAS NOT ABLE TO BE RETRACTED THROUGH THE 5FR SHEATH AND SUBSEQUENTLY DETACHED INSIDE THE SHEATH. THE BALLOON AND SHEATH WERE REMOVED TOGETHER AS ONE UNIT. ANOTHER BALLOON AND SHEATH WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7409954 ↗MalfunctionNov 20, 2017Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PTA BALLOON WAS ALLEGEDLY UNABLE TO BE RETRACTED FROM THE 5FR SHEATH. THE DEVICE AND SHEATH WERE REMOVED AS A SINGLE UNIT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7047511 ↗
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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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