Ultraverse® 035 PTA Dilatation Catheter U35130415Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741092220), received between Jan 4, 2021 and May 21, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 035 PTA BALLOON CATHETER TO TREAT FOR OCCLUDED FEMOROPOPLITEAL ARTERY. DURING THE PROCEDURE, IN THE PROCESS OF PRESSURIZATION, THE PRESSURE WAS ALLEGEDLY LEAKING. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED FROM THE PATIENT, AND FLUID WAS EJECTED FROM THE BALLOON BODY DURING RE-PRESSURIZATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059905 ↗
• MalfunctionMay 20, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE DORADO PTA BALLOON CATHETER PROCEDURE USING THE ULTRAVERSE 035. DURING THE PROCEDURE PRESSURE LEAKAGE IN THE PROCESS OF PRESSURIZATION, AND THEN THE PRESSURE VALUE DROPPED AUTOMATICALLY AFTER HITTING 15 ATM, AND THEN THE OBSERVATION IMAGE SHOWED THAT THERE WAS A LEAKAGE OF THE CONTRAST MEDIUM. ADDITIONALLY, IT WAS CONFIRMED THAT, RUPTURE OCCURRED DURING THE FIRST INFLATION, WITH A CIRCUMFERENTIAL RUPTURE AT THE DELIVERY ROD CONNECTION AND PRESSURIZATION WAS PERFORMED USING A PRESSURIZATION DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057979 ↗
• MalfunctionDec 16, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN A POPLITEAL ARTERY, THE PTA BALLOON WAS ALLEGEDLY RUPTURED DURING DILATATION. IT WAS FURTHER REPORTED THAT THERE WAS A DIFFICULTY IN RETRACTING THE BALLOON THRU THE INTRODUCER SHEATH AND IT WAS REMOVED AS A WHOLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20936216 ↗
• MalfunctionOct 7, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE BALLOON DELIVERY ROD WAS ALLEGEDLY FOUND TO BE BROKEN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20381652 ↗
• MalfunctionOct 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20365481 ↗
• MalfunctionSep 20, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON DELIVERER END ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20265681 ↗
• MalfunctionJul 10, 2024Leak/Splash; Device Dislodged or Dislocated; Leak/Splash; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED SUPERFICIAL FEMORAL ARTERY VIA THE RIGHT FEMORAL ARTERY, IT WAS ALLEGEDLY FOUND THAT THERE WAS LEAKAGE AT THE CONNECTION BETWEEN THE BALLOON BODY AND THE CATHETER UPON REMOVAL. IT WAS FURTHER REPORTED THAT THE BALLOON WAS WITHDRAWN FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19707862 ↗
• MalfunctionFeb 13, 2024Leak/Splash; Material Rupture; Material Deformation; Leak/Splash; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693829 ↗
• MalfunctionDec 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY CAME APART AT THE HUB. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18244692 ↗
• MalfunctionOct 13, 2023Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LOWER EXTREMITY ARTERY, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE INTRODUCER SHEATH, AND THE BALLOON AND THE INTRODUCER SHEATH WAS REMOVED 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 17929087 ↗
• MalfunctionMay 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED AND THUS LEAKED AIR. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14269890 ↗
• MalfunctionJan 4, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11106808 ↗