Ultraverse® RX U41502H15RXRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741056628), received between Aug 23, 2017 and Mar 25, 2026 — classified as 9 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 18, 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 25, 2026Material Rupture

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE VIA IPSILATERAL APPROACH USING THE ULTRAVERSE RX PTA BALLOON. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684178 ↗
• MalfunctionJul 2, 2025Material Rupture; Material Rupture

  A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE RX DEVICE. IT WAS REPORTED THAT THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 8 ATM. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381489 ↗
• MalfunctionNov 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 7 ATM ON THE FIRST INFLATION ATTEMPT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18179693 ↗
• MalfunctionNov 16, 2023Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155098 ↗
• MalfunctionMar 30, 2023Inflation Problem; Leak/Splash; Failure to Advance; Material Deformation; Inflation Problem; Leak/Splash; Failure to Advance; Material Deformation

  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 WAS ALLEGEDLY UNABLE TO CROSS THE LESION. IT WAS FURTHER REPORTED THAT THE SHAFT OF THE CATHETER ALLEGEDLY BENT AND CONTRAST LEAKED FROM THE CATHETER LUMEN WHEN THE PHYSICIAN PUSHED AND TRIED TO MAKE THE CATHETER CROSS THE LESION. REPORTEDLY, THE FAILURE TO INFLATE WAS FOUND OUTSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16653011 ↗
• MalfunctionApr 15, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF REPORTED INFORMATION INDICATES THAT MODEL U41502H15RX, PTA BALLOON DILATATION CATHETER, ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES. THESE MALFUNCTIONS INVOLVED PATIENTS WITH NO CONSEQUENCES. NEITHER PATIENTS' AGE, WEIGHT, OR GENDER WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9963765 ↗
• MalfunctionJan 15, 2020Material Deformation; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41502H15RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. THE PATIENT WAS REPORTED AS A 48-YEAR-OLD FEMALE WHOSE WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593733 ↗
• MalfunctionOct 16, 2019Material Deformation; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41502H15RX, PTA BALLOON DILATATION CATHETER, ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID NOT INVOLVE PATIENT. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9199809 ↗
• MalfunctionAug 23, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT IN PREPARATION FOR A PROCEDURE, THE PROXIMAL SIDE OF THE PTA BALLOON ALLEGEDLY WOULD NOT DEFLATE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6813415 ↗