Ultraverse® 035 PTA Dilatation Catheter U357586Recalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse 035 PTA Dilatation Catheter 8.0mm x 60mm balloon, 75cm 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
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741093968), received between May 3, 2017 and Aug 10, 2024 — classified as 2 injuries, 3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component4
- Material Rupture4
- Difficult to Remove2
- Material Split, Cut or Torn1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Injury1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 10, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY WAS DIFFICULT TO PASS THROUGH SHEATH VALVE DURING REMOVAL. IT WAS FURTHER REPORTED THAT IT NEARLY PULLED OUT THE SHEATH/ AND THEY NEARLY NEEDED TO REMOVE THE SHEATH AND LOOSE ACCESS. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19957126 ↗MalfunctionMar 17, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED ON INFLATION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13800436 ↗MalfunctionMay 27, 2021Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AND SEPARATED FROM CATHETER. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY HAD DIFFICULTY IN RETRACTING THE BALLOON THRU THE INTRODUCER SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11892874 ↗InjuryMay 12, 2020Material Rupture; Detachment of Device or Device Component; Material Split, Cut or Torn; Material Rupture; Detachment of Device or Device Component; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE BRACHIAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON TORE IN HALF AFTER THE DELIVERY SYSTEM BECAME STUCK ON THE GUIDEWIRE. REPORTEDLY, MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE DETACHED SEGMENT. THE DETACHED SEGMENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. PATIENT IS REPORTEDLY STABLE.
Patient problems: Injury
MAUDE report 10047828 ↗InjuryMay 3, 2017Retraction 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. FOLLOWING THE RUPTURE, THE HEALTH CARE PROVIDER WAS RETRACTING THE BALLOON THROUGH THE INTRODUCER SHEATH WHEN THE BALLOON ALLEGEDLY DETACHED INSIDE OF THE PATIENT. THE HEALTH CARE PROVIDER DECIDED TO PERFORM A SECONDARY PROCEDURE TO SUCCESSFULLY REMOVE THE DETACHED BALLOON SEGMENT. PATIENT STATUS IS UNKNOWN AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6542793 ↗
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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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