Ultraverse® RX U420038RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 3 mm x 80 mm, 200 cm Catheter · Class 2
All models of Ultraverse RX (56)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741056871), received between Jan 17, 2018 and Jan 17, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 16, 2026.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 17, 2018Material Rupture; Device Contamination with Chemical or Other Material; Material Rupture; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT UPON OPENING THE SEALED OUTER BOX, BLOOD WAS ALLEGEDLY FOUND ON THE OUTSIDE OF THE INNER PACKAGING. THE HEALTH CARE PROVIDER DECIDED TO USE THE PTA BALLOON AFTER REMOVAL FROM THE INNER PACKAGING. IT WAS FURTHER REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A VEIN GRAFT IN THE LEFT POSTERIOR TIBIAL, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 AM. THERE WAS NO REPORTED RETRACTION ISSUES. 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 7202390 ↗
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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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