Ultraverse® RX U41502H4RXRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741056475), received between Oct 27, 2020 and Jul 9, 2024 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2024Difficult to Open or Remove Packaging Material; Material Deformation; Difficult to Open or Remove Packaging Material; Material Deformation

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE TIP OF THE STYLET WAS ATTACHED TO THE PTA BALLOON AND IT ALLEGEDLY WOULD NOT COME OFF. IT WAS FURTHER REPORTED THAT THE TIP OF THE STYLET WAS ALLEGEDLY CRUSHED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19699516 ↗
• MalfunctionMar 25, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE SHAFT OF THE CATHETER ALLEGEDLY KINKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970625 ↗
• MalfunctionFeb 20, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738973 ↗
• InjuryOct 26, 2023Entrapment of Device; Failure to Advance; Detachment of Device or Device Component; Entrapment of Device; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE POPLITEAL ARTERY VIA A CONTRALATERAL APPROACH, THE CATHETER APPARENTLY GOT STUCK WITH THE STENT PLACED IN THE SUPERFICIAL FEMORAL ARTERY AND DETACHED BEFORE REACHING THE LESION. IT WAS FURTHER REPORTED THAT THE DETACHED SEGMENT WAS UNABLE TO BE REMOVED USING SNARE. REPORTEDLY, THE DETACHED SEGMENT WAS REMOVED BY SURGICALLY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 18009140 ↗
• MalfunctionMar 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A HIGHLY CALCIFIED TARGET LESION IN THE ANTERIOR TIBIAL ARTERY VIA AN IPSILATERAL ANTEGRADE APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED UNDER THE RATED BURST PRESSURE. 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 16653014 ↗
• MalfunctionFeb 15, 2023Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16376740 ↗
• MalfunctionJan 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A HIGHLY CALCIFIED TARGET LESION IN THE ANTERIOR TIBIAL ARTERY VIA AN IPSILATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6 ATM. 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 16200731 ↗
• InjuryMay 15, 2022Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY VIA CONTRALATERAL APPROACH, THE PTA BALLOON WAS ALLEGEDLY TRAPPED BY THE CALCIFICATION OF THE LESION AND UNABLE TO COME OFF. IT WAS FURTHER REPORTED THAT THE SHAFT WAS DETACHED FROM THE TIP AND FRAGMENTS REMAINED IN THE PATIENTS BODY. REPORTEDLY, THE RIGHT COMMON FEMORAL ARTERY WAS INCISED AND THE BALLOON SHAFT WAS TAKEN OUT. THE CURRENT PATIENT STATUS IS UNKNOWN.

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

  MAUDE report 14403833 ↗
• MalfunctionApr 15, 2021Material Discolored; Leak/Splash; Detachment of Device or Device Component; Device-Device Incompatibility; Material Discolored; Leak/Splash; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS DISCOLORED AND UNABLE TO DELIVER OVER GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11669876 ↗
• MalfunctionOct 27, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41502H4RX PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE AND WEIGHT OF MALE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10744034 ↗