Ultraverse® 014 U41502H15Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741053627), received between Jul 22, 2019 and Apr 26, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2022Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA FEMORAL ACCESS, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD SOME DIFFICULTY IN DELIVERING OUT THE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14203695 ↗
• MalfunctionOct 14, 2021Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PREPARATION OF AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON DETACHED FROM THE CATHETER WHILE PEELING AWAY THE PROTECTIVE SHEATH. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632845 ↗
• MalfunctionApr 17, 2020Break; Material Deformation; Break; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41502H15 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION AND BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE (B)(6) YEAR OLD MALE PATIENT WEIGHED (B)(6) KILOGRAMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9975193 ↗
• MalfunctionApr 15, 2020Break; Packaging Problem; Break; Packaging Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41502H15 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A BREAK AND PACKAGING PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION DID NOT INVOLVE A PATIENT. THE INTENDED PATIENT WAS REPORTEDLY A 66 YEAR OLD FEMALE OF UNKNOWN WEIGHT.

  Patient problems: No Patient Involvement

  MAUDE report 9963755 ↗
• MalfunctionJul 22, 2019Material Frayed; Peeled/Delaminated; Unraveled Material; Material Frayed; Peeled/Delaminated; Unraveled Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41502H15 PTA BALLOON DILATATION CATHETER ALLEGEDLY PEELED AND UNRAVELED. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THERE WAS NO PATIENT CONTACT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8811845 ↗