Ultraverse® RX U41502H25RXRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741056680), received between Jan 15, 2020 and Sep 16, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 18, 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.

• MalfunctionSep 16, 2025Break; Deflation Problem; Difficult to Insert; Difficult to Remove; Failure to Advance; Detachment of Device or Device Component; Device-Device Incompatibility; Break; Deflation Problem; Difficult to Insert; Difficult to Remove; Failure to Advance; Detachment of Device or Device Component; Device-Device Incompatibility

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX PTA BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SOME RESISTANCE AND DISCOMFORT DURING INSERTION. ADDITIONALLY, THE CATHETER COULD NOT BE DEFLATED AFTER USE AND EVEN APPLYING NEGATIVE PRESSURE WITH AN INDEFLATOR SYRINGE FAILED TO REMOVE IT. AN ATTEMPT WAS MADE TO REMOVE THE ENTIRE SHEATH, BUT THE SHAFT BROKE OFF. THE WIRE REMAINED IN THE LUMEN, SO IT WAS RETRIEVED USING A GUIDING CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23060662 ↗
• MalfunctionMay 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN AN ANTERIOR TIBIAL ARTERY LESION WITH CALCIFICATION IN THE IPSILATERAL APPROACH, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT NOMINAL 6 ATM PRESSURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236905 ↗
• MalfunctionMay 18, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE DAMAGE WAS FOUND AT THE PROXIMAL PART AFTER REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14433262 ↗
• MalfunctionMay 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT NOMINAL 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 11875183 ↗
• MalfunctionMar 5, 2021Deflation Problem; Inflation Problem; Material Deformation; Deflation Problem; Inflation Problem; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY FAILED TO INFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON SUCCESSFULLY INFLATED OUTSIDE THE PATIENT'S BODY, BUT ALLEGEDLY FAILED TO DEFLATE. REPORTEDLY, ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11419502 ↗
• MalfunctionJan 15, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41502H25RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION AND FAILURE TO ADVANCE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS A (B)(6) YEAR OLD MALE; WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591799 ↗