Ultraverse® RX U415034RXRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741056802), received between Jul 22, 2019 and Feb 17, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Material Rupture

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363360 ↗
• MalfunctionJan 29, 2026Material Rupture

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE BY USING THE ULTRAVERSE RX BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206853 ↗
• MalfunctionOct 16, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE RX PTA BALLOON CATHETER VIA IPSILATERAL APPROACH. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23307620 ↗
• MalfunctionMar 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21570071 ↗
• MalfunctionJan 11, 2025Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA IPSILATERAL ANTEGRADE APPROACH, THE PTA BALLOON WAS ALLEGEDLY BROKEN OFF AT THE HUB PART AT THE BASE OF THE SHAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21132753 ↗
• MalfunctionJan 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE MODERATELY CALCIFIED STENOTIC LESION, THE PTA BALLOON ALLEGEDLY RUPTURED BELOW NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21076060 ↗
• MalfunctionJun 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN SUPERFICIAL ARTERY LESION VIA CONTRALATERAL APPROACH, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 6 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19517386 ↗
• MalfunctionFeb 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED DURING DILATION AT 6 BAR. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18694523 ↗
• MalfunctionNov 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED AT 8 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18210702 ↗
• MalfunctionSep 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED AND OCCLUDED TARGET LESION BELOW THE KNEE IN THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED. 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 17708906 ↗
• MalfunctionFeb 2, 2023Leak/Splash; Material Rupture; Material Split, Cut or Torn; Leak/Splash; Material Rupture; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION OF CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY VIA A RIGHT CONTRALATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 2 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16281955 ↗
• MalfunctionMay 31, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION IN THE POPLITEAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AROUND RATED BURST PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547608 ↗
• MalfunctionApr 6, 2022Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CEPHALIC VEIN, THE PTA BALLOON ALLEGEDLY GOT STUCK IN THE GUIDEWIRE AND WAS DIFFICULT TO REMOVE WHEN THE PHYSICIAN ADJUSTED THE POSITION OF THE BALLOON. IT WAS FURTHER REPORTED THAT THE BALLOON AND GUIDEWIRE WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14020646 ↗
• MalfunctionDec 21, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A HIGHLY CALCIFIED TARGET LESION IN THE LEFT ANTERIOR TIBIAL ARTERY VIA AN IPSILATERAL ANTEGRADE APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED UNDER NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13051811 ↗
• MalfunctionMay 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805750 ↗
• MalfunctionApr 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY VIA THE IPSILATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 4 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11626249 ↗
• MalfunctionMar 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF HIGHLY CALCIFIED LEGION, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT ANOTHER PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431132 ↗
• MalfunctionDec 11, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER SHAFT WAS ALLEGEDLY KINKED AND UNABLE TO CROSS LESION. 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 10990460 ↗
• MalfunctionOct 27, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U415034RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE MALE PATIENT'S AGE AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10738948 ↗
• MalfunctionOct 27, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THE MODEL U415034RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION, AND FAILURE TO ADVANCE. THE REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT'S AGE, GENDER, AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10738913 ↗
• MalfunctionJul 22, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES FOUR MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U415034RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THESE MALFUNCTIONS INVOLVED PATIENTS WITH NO CONSEQUENCES. TWO PATIENTS RANGED FROM 76-83 YEARS OF AGE AND 63-70 KGS. OF THE REPORTED PATIENTS, TWO WAS MALE AND ONE WERE FEMALE. ALL REMAINING PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10311009 ↗
• MalfunctionApr 15, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U415034RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. BOTH EVENTS DID INVOLVE PATIENTS WITH NO REPORTED PATIENT INJURY. ONE PATIENT IS (B)(6) OLD, (B)(6) , AND FEMALE; HOWEVER, THE SECOND PATIENTS¿ WEIGHT, GENDER AND AGE WERE NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9963690 ↗
• MalfunctionJan 15, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U415034RX ULTRAVERSE RX PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES. OUT OF THE TWO REPORTED MALFUNCTIONS, BOTH PATIENTS WERE INVOLVED WITH NO PATIENT CONSEQUENCE OR IMPACT. ONE PATIENT WAS A MALE, NO AGE AND WEIGHT INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9594167 ↗
• MalfunctionOct 22, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U415034RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS FEMALE AND AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9219897 ↗
• MalfunctionOct 21, 2019Material Deformation; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U415034RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID INVOLVE A PATIENT WITH NO PATIENT INJURY. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9216282 ↗