Ultraverse® RX U4150425RXRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741057670), received between Apr 15, 2020 and Jun 28, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA ANTEGRADE APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED DURING THE FIRST DILATION 10 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19631960 ↗
• MalfunctionMar 14, 2023Failure to Advance; Device-Device Incompatibility; Material Deformation; Failure to Advance; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA AN IPSILATERAL ANTEGRADE APPROACH, THERE WAS STRONG RESISTANCE FELT AND THE DEVICE ALLEGEDLY FAILED TO BE ADVANCED OVER THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT THE SHAFT OF THE CATHETER WAS ALLEGEDLY KINKED AND WIRE LUMEN CRUSHED. THE BALLOON AND THE GUIDEWIRE WERE REMOVED TOGETHER 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 16535323 ↗
• MalfunctionJul 22, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE, THE CATHETER SHAFT WAS ALLEGEDLY KINKED . 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 12208191 ↗
• MalfunctionJan 22, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER SHAFT WAS ALLEGEDLY KINKED AND THE PTA BALLOON WAS ALLEGEDLY UNABLE TO CROSS THE LESION. IT WAS FURTHER REPORTED THAT ANOTHER PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11213839 ↗
• MalfunctionNov 3, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF LONG CHRONIC TOTAL OCCLUSION OF CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY VIA IPSILATERAL ANTE GRADE APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6 ATM. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10782975 ↗
• MalfunctionApr 15, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150425RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE MALFUNCTIONS EACH INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. ONE PATIENT WAS MALE; ALL OTHER PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9963414 ↗