Ultraverse® 014 U4150230Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741064425), received between Aug 30, 2017 and Feb 16, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY BROKE THROUGH THE SHEATH IN THE PROCESS OF DECOMPRESSING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18719208 ↗
• MalfunctionNov 18, 2022Material 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 15823816 ↗
• MalfunctionJan 14, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150230 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS REPORTEDLY A (B)(6) YEAR OLD MALE WEIGHING (B)(6) KILOGRAMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9587242 ↗
• MalfunctionOct 3, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT POSTERIOR TIBIAL ARTERY, ACCESS WAS GAINED IN THE RIGHT FEMORAL ARTERY, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO DEFLATE. THE PROCEDURE WAS COMPLETED UPON REMOVAL OF THE PTA BALLOON, WITH NO FURTHER TREATMENT PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7932187 ↗
• MalfunctionSep 6, 2018Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE TIBIAL ARTERY, THE PTA BALLOON HAD INCOMPATIBILITY ISSUES WITH THE GUIDE WIRE. NO FURTHER TREATMENT WAS NEEDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7852763 ↗
• InjuryAug 15, 2018Retraction Problem; Device-Device Incompatibility; Retraction Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON WAS ALLEGEDLY GETTING CAUGHT ON THE GUIDEWIRE AND SUBSEQUENTLY COULD NOT BE RETRACTED. THE BALLOON AND GUIDEWIRE WERE REMOVED AS ONE UNIT. REPORTEDLY, THE AMPUTATION OF PATIENT'S LEG WAS PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7785834 ↗
• MalfunctionFeb 7, 2018Detachment of Device or Device Component; Device-Device Incompatibility; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SFA, THE PTA BALLOON ALLEGEDLY BECAME STUCK ON THE GUIDEWIRE AFTER THE FIRST INFLATION. REPORTEDLY, THE BALLOON CATHETER AND GUIDEWIRE WERE REMOVED AS ONE UNIT AND A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7249960 ↗
• MalfunctionAug 30, 2017Deflation Problem; Retraction Problem; Device-Device Incompatibility; Deflation Problem; Retraction Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT POSTERIOR TIBIAL ARTERY, THE PTA BALLOON ALLEGEDLY WOULD NOT DEFLATE AFTER THE FIRST INFLATION. REPORTEDLY DURING RETRACTION THE BALLOON ALLEGEDLY GOT STUCK ON THE GUIDEWIRE; THEREFORE, THE PTA BALLOON AND GUIDEWIRE WERE REMOVED THROUGH INTRODUCER SHEATH WITHOUT INCIDENT. A NEW GUIDEWIRE AND ANOTHER BALLOON WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6831815 ↗