Ultraverse® RX U4150225RXRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741056352), received between Apr 15, 2020 and Dec 13, 2024 — classified as 13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE SHAFT WAS ALLEGEDLY BROKE MIDWAY. IT WAS FURTHER REPORTED THAT IT COULD NOT BE BROUGHT TO THE LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20922455 ↗
• MalfunctionJul 6, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19685282 ↗
• MalfunctionJun 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT NOMINAL LEVEL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19622006 ↗
• MalfunctionMar 12, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885292 ↗
• MalfunctionMar 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841237 ↗
• MalfunctionNov 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA AN IPSILATERAL APPROACH, CONTRAST LEAKAGE WAS ALLEGEDLY OCCURRED WHEN THE PTA BALLOON WAS DIALATED TO 6 ATM. IT WAS FURTHER REPORTED THAT THE PTA BALLOON WAS ALLEGEDLY DETERMINED TO BE RUPTURED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18203524 ↗
• MalfunctionFeb 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LEGION, THE PTA BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277759 ↗
• MalfunctionDec 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16059491 ↗
• MalfunctionJun 7, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE NEAR THE RIGHT POSTERIOR TIBIAL ARTERY, THE CATHETER SHAFT OF THE PTA BALLOON ALLEGEDLY KINKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14611798 ↗
• MalfunctionJan 21, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION BELOW THE KNEE, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO CROSS THE LESION AND THE CATHETER SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314887 ↗
• MalfunctionJul 22, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150225RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. THREE MALFUNCTIONS WERE INVOLVED WITH NO PATIENT CONSEQUENCES. THE AGE, GENDER AND WEIGHT OF ALL THE THREE PATIENTS WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10306518 ↗
• MalfunctionJul 21, 2020Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL U4150225RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION AND INFLATION PROBLEM. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. A MALE PATIENT'S AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10305978 ↗
• MalfunctionApr 15, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150225RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. EACH OF THE TWO MALFUNCTIONS INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. ONE PATIENT WAS MALE; ALL OTHER PATIENT AGE, WEIGHT, AND GENDER WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9963904 ↗