Ultraverse® RX U415038RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 3 mm x 80 mm, 150 cm Catheter · Class 2
All models of Ultraverse RX (56)
Data updated Oct 16, 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 00801741056864), received between Oct 10, 2017 and Apr 24, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Retraction Problem2
- Break1
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2018Retraction Problem; Material Rupture; Detachment of Device or Device Component; Retraction Problem; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY RUPTURED. REPORTEDLY, BALLOON SEGMENTS DETACHED FROM THE BALLOON CATHETER AND THE USE OF A SNARE DEVICE WAS USED TO RECOVER THE BALLOON SEGMENTS SUCCESSFULLY. REPORTEDLY, THE BALLOON AND SHEATH WERE REMOVED TOGETHER AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7456957 ↗MalfunctionOct 10, 2017Break; Retraction Problem; Detachment of Device or Device Component; Break; Retraction Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY SEPARATED IN HALF DURING REMOVAL THROUGH THE SHEATH POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE BALLOON MATERIAL ALLEGEDLY DETACHED FROM THE CATHETER SHAFT. THE PROCEDURE WAS CONCLUDED, AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6936554 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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