Ultraverse® 035 PTA Dilatation Catheter U357568Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 6.0mm x 80mm 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741092978), received between Mar 20, 2017 and Oct 16, 2025 — classified as 5 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
- Leak/Splash2
- Break1
- Device Dislodged or Dislocated1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2025Leak/Splash; Device Dislodged or Dislocated; Leak/Splash; Device Dislodged or Dislocated
ON (B)(6) 2025, THE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE IN SUPERFICIAL FEMORAL ARTERY USING THE ULTRAVERSE 035 PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY DOES NOT INFLATE. IT WAS FURTHER REPORTED THAT THE SALINE SOLUTION LEAK WAS LOCATED AT THE JOINT BETWEEN THE CATHETER CARRIER AND THE HUB WITH THE LUER-LOCK PORTS. THE STRAIN RELIEF WAS OBSERVED TO BE SEPARATED FROM THE Y-BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23307855 ↗MalfunctionApr 20, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD BALLOON RUPTURE. 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 11691595 ↗MalfunctionMay 25, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING A PTA PROCEDURE, THE BALLOON ALLEGEDLY OBTAINED A CIRCUMFERENTIAL RUPTURE. THERE WAS NO REPORTED ISSUE REMOVING THE BALLOON THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7545633 ↗MalfunctionSep 27, 2017Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED ON THE SECOND INFLATION ATTEMPT. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6897848 ↗MalfunctionMar 20, 2017Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE AN ALLEGED LEAK WAS OBSERVED ON THE CATHETER OF THE PTA BALLOON. REPORTEDLY, ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6419648 ↗
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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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