Ultraverse® 035 PTA Dilatation Catheter U357594Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741094347), received between Jan 6, 2021 and Jun 9, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (5 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 035 PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED AT 8 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165367 ↗
• MalfunctionFeb 13, 2025Difficult to Insert; Difficult to Remove; Stretched; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation; Difficult to Insert; Difficult to Remove; Stretched; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation

  ON (B)(6) 2024, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING ULTRAVERSE 035 DILATATION CATHETER. DURING THE PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO REMOVE THROUGH THE SHEATH. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS LEFT AND SWITCHED THE SHEATH TO KEEP ACCESS TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21371422 ↗
• MalfunctionOct 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM WHEN THE LESION EXPANDS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490925 ↗
• InjuryJun 12, 2023Difficult 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. IT WAS FURTHER REPORTED THAT THREE CENTIMETER OF THE PTA BALLOON WAS ALLEGEDLY REMAINED IN THE VESSEL AND WAS UNABLE TO REMOVE THE PIECE. REPORTEDLY, THE PTA BALLOON PIECE WAS ATTACHED TO THE VESSEL WALL WITH A STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 17105360 ↗
• MalfunctionJun 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 7ATM AT THE FIRST INFLATION ATTEMPT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14840133 ↗
• MalfunctionApr 7, 2022Difficult to Insert; Difficult to Remove; Device-Device Incompatibility; Difficult to Insert; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE BELOW THE KNEE, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO INSERT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS HARD TO REMOVE AFTER INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14039674 ↗
• MalfunctionDec 13, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY STUCK UPON REMOVING FROM THE SHEATH. IT WAS FURTHER REPORTED THAT DEVICE WAS REMOVED AS SINGLE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12982337 ↗
• MalfunctionJan 6, 2021Break; Entrapment of Device; Difficult to Remove; Retraction Problem; Detachment of Device or Device Component; Break; Entrapment of Device; Difficult to Remove; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY STUCK AND UNABLE TO REMOVE. IT WAS FURTHER REPORTED THAT THE SHAFT OF THE CATHETER ALLEGEDLY BROKE. THE BALLOON AND THE SHEATH WERE REMOVED TOGETHER AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11123016 ↗