Ultraverse® 035 PTA Dilatation Catheter U3513056Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 5.0mm x 60mm 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
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741092688), received between Oct 22, 2021 and Jun 8, 2022 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
- Device-Device Incompatibility1
- Difficult to Remove1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Tachycardia1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
DeathJun 8, 2022Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE GUIDEWIRE STUCK AND UNABLE TO RETRIEVE BACK INTO THE SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON SNAPPED OFF FROM THE BALLOON CATHETER SHAFT AND SEPARATED, LEAVING BALLOON PORTION INSIDE THE PATIENT'S RIGHT EXTERNAL ILLIAC. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Tachycardia
MAUDE report 14629711 ↗MalfunctionOct 22, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE INGUINAL LIGAMENT ACCESS VIA A COMMON FEMORAL PUNCTURE TO TREAT THE LEFT POPLITEAL ARTERY STENOSIS, CONTRAST SOLUTION WAS ALLEGEDLY FOUND TO BE LEAKING AT THE PROXIMAL PORTION OF THE BALLOON. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED AND HOLE WAS OBSERVED AT PROXIMAL END. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12681656 ↗
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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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