Ultraverse® 035 PTA Dilatation Catheter U35130128Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741094965), received between Jan 10, 2022 and Nov 3, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23448823 ↗
• MalfunctionAug 27, 2024Deflation Problem; Leak/Splash; Deflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON CATHETER ADAPTER ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT PHYSICIAN BROKEN IT WITH AN ANOTHER NEEDLE TO GET IT OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20074762 ↗
• MalfunctionAug 27, 2024Deflation Problem; Leak/Splash; Deflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON CATHETER ADAPTER HAD ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT THE PTA BALLOON CATHETER ALLEGEDLY BROKE WITH A NEEDLE TO GET IT OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20074524 ↗
• MalfunctionJul 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY LEAKED AND BECAME UNUSABLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19736788 ↗
• MalfunctionJul 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON HAD ALLEGEDLY LEAKED AND BECAME UNUSABLE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19726164 ↗
• MalfunctionMar 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT ILIOFEMORAL VEIN, RUPTURE WAS ALLEGEDLY NOTED AT THE JUNCTION BETWEEN BASEPLATE AND CARRIER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874456 ↗
• MalfunctionMar 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT ILIOFEMORAL VEIN, THE RUPTURE WAS ALLEGEDLY NOTED AT THE JUNCTION BETWEEN BASEPLATE AND CARRIER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874455 ↗
• MalfunctionJan 10, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED BETWEEN THE SHAFT AND THE CONNECTOR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18481760 ↗
• MalfunctionJan 10, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED BETWEEN THE SHAFT AND THE CONNECTOR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18481753 ↗
• MalfunctionSep 6, 2023Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FOR INFERIOR VENA CAVA STENOSIS AND IN-STENT RESTENOSIS IN THE ILIAC VEIN VIA THE FEMORAL VEIN, THE PTA BALLOON ALLEGEDLY BURST IN THE BODY OF THE PATIENT SUDDENLY WHEN THE PRESSURE WAS INCREASED TO 6 ATM. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE INTRODUCER SHEATH FOLLOWING THE BALLOON RUPTURE AND WERE RETRIEVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17689750 ↗
• MalfunctionJan 10, 2022Difficult to Remove; Material Rupture; Material Deformation; Difficult to Remove; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF LEFT LOWER EXTREMITY DEEP VENOUS THROMBOSIS IN THE RIGHT FEMORAL VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED LONGITUDINALLY. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY HAD DIFFICULTY IN RETRACTING THRU THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13202980 ↗