Ultraverse® RX U4150315RXRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741056956), received between Jan 3, 2017 and Apr 23, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA IPSILATERAL ANTEGRADE APPROACH, THE PTA BALLOON WAS ALLEGEDLY BROKEN DURING EXPANSION AT 4 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889643 ↗
• MalfunctionApr 21, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY IN IPSILATERAL PUNCTURE POPLITEAL CASE, THE PTA BALLOON ALLEGEDLY FELT RESISTANCE WHILE PASSING THROUGH THE WIRE. IT WAS FURTHER REPORTED THAT THERE WAS POOR EXPANSION AT 6 ATMOSPHERES, SO THE PRESSURE WAS INCREASED TO 8 ATMOSPHERES AND RUPTURE WAS CONFIRMED AT 8 ATMOSPHERES. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871868 ↗
• MalfunctionOct 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A HIGHLY CALCIFIED TARGET LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY, THE PTA BALLOON WAS ALLEGEDLY RUPTURED UNDER 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 17963458 ↗
• MalfunctionAug 26, 2022Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE BELOW THE RIGHT KNEE VIA AN IPSILATERAL APPROACH, THE PTA BALLOON WAS ALLEGEDLY 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 15300009 ↗
• MalfunctionJul 18, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY VIA AN IPSILATERAL ANTEGRADE APPROACH, THE SHAFT OF THE CATHETER ALLEGEDLY BENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15037019 ↗
• MalfunctionMar 4, 2022Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13666869 ↗
• MalfunctionMay 19, 2021Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF HIGHLY CALCIFIED LESION, THE PTA BALLOON ALLEGEDLY RUPTURED AT ABOUT 10 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11847045 ↗
• MalfunctionFeb 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF HIGHLY CALCIFIED LESION, 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 11327011 ↗
• MalfunctionJul 22, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150315RX PTA BALLOON 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, SEX AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10307790 ↗
• MalfunctionApr 15, 2020Break; Detachment of Device or Device Component; Device-Device Incompatibility; Break; Detachment of Device or Device Component; Device-Device Incompatibility

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150315RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A BREAK, DETACHMENT OF THE DEVICE OR A DEVICE COMPONENT, AND DEVICE-DEVICE INCOMPATIBILITY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS REPORTEDLY A (B)(6) OLD MALE WEIGHING (B)(6) .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9963686 ↗
• MalfunctionOct 21, 2019Failure to Advance; Device-Device Incompatibility; Material Deformation; Failure to Advance; Device-Device Incompatibility; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150315RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED FAILURE TO ADVANCE, DEVICE-DEVICE INCOMPATIBILITY, AND MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. THE MALE PATIENT IS (B)(6) YEARS OLD AND WEIGHS (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9216277 ↗
• MalfunctionJan 3, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT FOLLOWING DILATION OF THE ANTERIOR TIBIAL ARTERY, A SEGMENT OF THE PTA BALLOON ALLEGEDLY DETACHED WITHIN THE PATIENT. A SNARE DEVICE WAS USED TO CAPTURE AND RETRIEVE DETACHED SEGMENT WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6220137 ↗