Ultraverse® RX U4150415RXRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741057618), received between Aug 10, 2017 and Aug 18, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Material Deformation; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING AN ULTRAVERSE RX BALLOON IN THE SUPERFICIAL FEMORAL ARTERY VIA IPSILATERAL APPROACH, THE SHAFT ALLEGEDLY KINKED AFTER SEVERAL ATTEMPTS AND BECAME UNUSABLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22825157 ↗
• MalfunctionNov 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A HIGHLY CALCIFIED AND CHRONIC TOTAL OCCLUSION 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 15796130 ↗
• MalfunctionSep 12, 2022Break; Difficult to Remove; Material Rupture; Device-Device Incompatibility; Material Twisted/Bent; Material Split, Cut or Torn; Break; Difficult to Remove; Material Rupture; Device-Device Incompatibility; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY VIA A CONTRALATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT NOMINAL PRESSURE AND ALSO THE GUIDEWIRE WAS BENT AT THE SAME TIME. IT WAS FURTHER REPORTED THAT THERE WAS RESISTANCE FELT UPON THE BALLOON WAS RETRACING AND THE SHAFT WAS FOUND TO BE TORN. REPORTEDLY, THE BALLOON AND THE GUIDEWIRE WERE REMOVED 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 15400397 ↗
• MalfunctionJul 22, 2022Contamination; Contamination

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE DEVICE ALLEGEDLY FELL ON THE FLOOR. 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 15082713 ↗
• MalfunctionJul 22, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL U4150415RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10308128 ↗
• MalfunctionApr 15, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150415RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS A 73 YEAR OLD MALE. WEIGHT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9963546 ↗
• MalfunctionJan 16, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL U4150415RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. THE (B)(6) YEAR OLD MALE WEIGHED (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9598181 ↗
• MalfunctionJan 15, 2020Failure 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 U4150415RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED FAILURE TO ADVANCE AND MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9592010 ↗
• MalfunctionAug 10, 2017Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT AFTER FLUSHING THE PTA BALLOON CATHETER, THE CATHETER WAS INSERTED INTO A STENOSED SFA AND BLOOD ALLEGEDLY FLOWED INTO THE BALLOON. THE HEALTH CARE PROVIDER ALLEGED THE BALLOON MAY HAVE RUPTURED. THE BALLOON CATHETER WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6786866 ↗