Ultraverse® 035 PTA Dilatation Catheter U35130124Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 12.0mm x 40mm 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741094941), received between Aug 7, 2017 and Dec 20, 2021 — classified as 2 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.
Most reported problems
Device problems
- Material Rupture2
- Detachment of Device or Device Component1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 20, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH LEFT POPLITEAL VEIN APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED CIRCUMFERENTIALLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13042949 ↗MalfunctionAug 7, 2017Retraction Problem; Material Rupture; Detachment of Device or Device Component; Retraction Problem; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PTA BALLOON CATHETER ALLEGEDLY RUPTURED (ATM UNKNOWN) DURING THE SECOND INFLATION IN THE RIGHT INTERNAL JUGULAR VEIN. IT WAS FURTHER REPORTED THAT DURING RETRACTION OF THE BALLOON CATHETER THROUGH THE SHEATH, THE BALLOON BECAME LODGED AND DETACHED WITHIN THE SHEATH. THE HEALTH CARE PROVIDER (HCP) CUT AND REMOVED THE HEMOSTATIC VALVE FROM THE SHEATH AND INSERTED A 12 FR SHEATH OVER THE 7 FR SHEATH. BOTH SHEATHS WERE REMOVED AS A SINGLE UNIT; HOWEVER, WHILE EXITING THE ACCESS SITE, THE BALLOON DISLODGED FROM THE SHEATH AND REMAINED AT THE ACCESS SITE. THE HCP USED FORCEPS TO CAPTURE AND REMOVE THE BALLOON FROM THE PATIENT. REPORTEDLY, ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6772522 ↗
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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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