Ultraverse® RX U42001H4RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 1.5 mm x 40 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
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741055881), received between Feb 18, 2020 and Feb 18, 2020 — classified as 1 death.
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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Retraction Problem1
Patient problems
- Death1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathFeb 18, 2020Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT ANTERIOR TIBIAL ARTERY VIA RIGHT FEMORAL ARTERY, THE PTA BALLOON CATHETER ALLEGEDLY HAD RETRACTION DIFFICULTIES AND DETACHED INSIDE THE PATIENT. REPORTEDLY, ATTEMPTS WERE MADE VIA BALLOONS INFLATIONS AND/OR SNARING FOR RETRIEVAL OF CATHETER WITHIN THE PATIENT¿S LEFT LEG. AFTER TWO HOURS, DECISION WAS MADE TO SEND PATIENT TO SURGERY FOR REMOVAL OF THE BALLOON. THE DETACHED SEGMENT WAS REMOVED DURING SURGERY, HOWEVER, THE PATIENT EXPIRED TWO DAYS POST-SURGERY.
Patient problems: Death
MAUDE report 9720521 ↗
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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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