Ultraverse® 035 PTA Dilatation Catheter U351301210Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 12.0mm x 100mm balloon, 130cm 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741094972), received between Apr 15, 2019 and Sep 8, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 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 Rupture2
- Break1
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Difficult to Remove1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 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 PROCEDURE THE SALINE ALLEGEDLY LEAKED AT THE CONNECTING ROD. IT WAS FURTHER REPORTED THAT THE PRESSURE VALUE WAS AUTOMATICALLY DECREASED AFTER HITTING 15 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22994311 ↗MalfunctionDec 6, 2021Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH STENOTIC AND OCCLUDED AREA IN THE RIGHT ILIAC-FEMORAL VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM. IT WAS FURTHER REPORTED THAT DURING RETRIEVAL OF BALLOON INTO THE SHEATH, THE BALLOON SHAFT ALLEGEDLY BROKE AND HAD DIFFICULTY IN RETRACTING THE BALLOON THRU THE INTRODUCER SHEATH. THE BALLOON WAS REMOVED FROM THE PATIENT ALONG WITH THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12932112 ↗MalfunctionApr 15, 2019Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL U351301210 PTA BALLOON DILATATION CATHETER EXPERIENCED A MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8516487 ↗
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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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