Ultraverse® 014 U41502H30Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741064449), received between Apr 15, 2019 and Mar 3, 2025 — classified as 1 injury, 8 malfunctions.

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

• MalfunctionMar 3, 2025Deflation Problem; Inflation Problem; Difficult to Remove; Material Twisted/Bent; Deflation Problem; Inflation Problem; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY WOULD NOT DEFLATE. IT WAS FURTHER REPORTED THAT IT WAS ALLEGEDLY PUMPED BACK UP WITH SALINE ONLY, AFTER SECOND SALINE INJECTION, THEY WERE ABLE TO DEFLATE BALLOON ENOUGH TO REMOVE IT. REPORTEDLY, THE PTA BALLOON WAS ALLEGEDLY TWISTED DISTALLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511001 ↗
• MalfunctionOct 19, 2023Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Advance; Material Deformation; Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE BELOW THE KNEE VIA AN IPSILATERAL ANTEGRADE APPROACH, THERE WAS A RESISTANCE FELT UPON INSERTING. IT WAS FURTHER REPORTED THAT THE CATHETER SHAFT OF THE PTA BALLOON ALLEGEDLY KINKED AND DETACHED AS THE PHYSICIAN APPLIED FORCE TO ADVANCE. REPORTEDLY, THE KINK AND DETACHMENT WERE ALLEGEDLY OCCURRED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17963356 ↗
• MalfunctionSep 26, 2022Device Damaged Prior to Use; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Material Deformation; Device Damaged Prior to Use; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Material Deformation

  IT WAS REPORTED THAT DURING PREPARATION OF AN ANGIOPLASTY PROCEDURE, THE PHYSICIAN ALLEGEDLY FELT LOT OF RESISTANCE WHILE REMOVING THE BALLOON PROTECTION COVER. IT WAS FURTHER REPORTED THAT THE BALLOON PART ALLEGEDLY GOT DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15483638 ↗
• MalfunctionOct 7, 2021Peeled/Delaminated; Device Damaged Prior to Use; Device Contamination with Chemical or Other Material; Peeled/Delaminated; Device Damaged Prior to Use; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12587765 ↗
• InjuryDec 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN CALCIFIED LESION, THE BALLOON ALLEGEDLY DETACHED OF THE CATHETER. IT WAS FURTHER REPORTED THAT THE BALLOON STUCK INSIDE THE PATIENT AND MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE COMPONENT. THE PATIENT CURRENT STATUS WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11011165 ↗
• MalfunctionJul 22, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL U41502H30 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE MALE PATIENT IS (B)(6) YEARS OLD AND WEIGHS (B)(6) POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10310777 ↗
• MalfunctionOct 22, 2019Peeled/Delaminated; Peeled/Delaminated

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4102H30 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED PEELED MATERIAL. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. BOTH EVENTS INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9219899 ↗
• MalfunctionJul 24, 2019Material Frayed; Material Deformation; Material Frayed; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41502H30 PTA BALLOON DILATATION CATHETER ALLEGEDLY HAD FRAYED MATERIAL. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITHOUT CONSEQUENCE. THE AGE, WEIGHT, AND SEX OF THE INVOLVED PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8823127 ↗
• MalfunctionApr 15, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL U41502H30 PTA DILATATION CATHETER EXPERIENCED A DETACHMENT OF DEVICE OR COMPONENT. THIS EVENT WAS REPORTED FROM A SINGLE SOURCE. THIS EVENT INVOLVED A PATIENT WITH NO REPORTED INJURY. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8516815 ↗