Ultraverse® RX U4200210RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 2 mm x 100 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741056246), received between Feb 9, 2018 and Aug 8, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 Component4
- Break1
- Difficult to Advance1
- Difficult to Remove1
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA FEMORAL ACCESS, THE PTA BALLOON SHAFT ALLEGEDLY GOT SNAPPED IN HALF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15181699 ↗MalfunctionJun 28, 2021Inflation Problem; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Inflation Problem; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO ADVANCE AND DIFFICULT TO REMOVE. IT WAS FURTHER REPORTED THAT THE BALLOON DETACHED FROM THE CATHETER AND HAD INFLATION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12073502 ↗MalfunctionJul 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4200210RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED CATHETER DETACHMENT. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10308374 ↗MalfunctionFeb 9, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE TIBIAL ARTERY, A BREAK WAS ALLEGEDLY IDENTIFIED ON THE CATHETER SHAFT OF THE PTA BALLOON DEVICE . THE 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 7260364 ↗
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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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