ULTRASCORE US14150515Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741113970), received between Jul 16, 2019 and Aug 25, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Difficult to Remove; Failure to Advance; Device-Device Incompatibility

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 014 PTA BALLOON CATHETER. DURING THE PROCEDURE AFTER PASSING THE GUIDEWIRE IT WAS ATTEMPTED TO BE REMOVED, BUT IT BECAME STUCK WITH THE GUIDEWIRE AND WAS REMOVED TOGETHER WITH IT. IT WAS DELIVERED IN ORDER TO BE USED AGAIN, BUT THERE WAS STRONG RESISTANCE UPON DELIVERY AND ALSO UPON REMOVAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882005 ↗
• MalfunctionDec 13, 2024Material Puncture/Hole; Difficult to Remove; Material Rupture; Device-Device Incompatibility; Material Deformation; Material Puncture/Hole; Difficult to Remove; Material Rupture; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE WIRE ALLEGEDLY GOT STUCK AND COULD NOT BE PULLED OUT. REPORTEDLY, THE ENTIRE DEVICE WAS REMOVED AND A NEW WIRE WAS INSERTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20922422 ↗
• MalfunctionNov 14, 2024Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Difficult to Remove; Failure to Advance; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE CATHETER ALLEGEDLY ATTEMPTED TO REMOVE, BUT THE WIRE WAS PULLED OUT AND REMOVED. IT WAS FURTHER REPORTED THAT ATTEMPTED TO DELIVER AGAIN BUT WAS UNABLE TO DELIVER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20680383 ↗
• MalfunctionOct 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN SUPERFICIAL FEMORAL ARTERY VIA IPSILATERAL ANTEGRADE APPROACH, THE BALLOON WAS ALLEGEDLY RUPTURED AT 3-4 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20492199 ↗
• MalfunctionApr 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH CONTRALATERAL APPROACH, THE PTA BALLOON 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 19021473 ↗
• MalfunctionNov 2, 2023Failure to Advance; Device-Device Incompatibility; Material Deformation; Material Split, Cut or Torn; Failure to Advance; Device-Device Incompatibility; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE GUIDEWIRE WAS ALLEGEDLY UNABLE TO BE INSERTED THROUGH THE CATHETER BECAUSE THE CONNECTION PART OF THE HUB AND THE CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18054603 ↗
• MalfunctionJul 5, 2023Failure to Advance; Device-Device Incompatibility; Device Dislodged or Dislocated; Failure to Advance; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA A CROSSOVER APPROACH, THE GUIDEWIRE ALLEGEDLY GOT STUCK AND THE PTA BALLOON WAS UNABLE TO BE ADVANCED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17255202 ↗
• MalfunctionJan 31, 2023Difficult to Remove; Material Rupture; Device-Device Incompatibility; Difficult to Remove; Material Rupture; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT THE RATED BURST PRESSURE. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE ALLEGEDLY GOT STUCK UPON REMOVAL. REPORTEDLY, THE BALLOON AND THE 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 16270889 ↗
• MalfunctionOct 18, 2022Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE BETWEEN THE POPLITEAL ARTERY AND THE SUPERFICIAL FEMORAL ARTERY VIA A CONTRALATERAL APPROACH, THE PTA BALLOON ALLEGEDLY GOT STUCK WITH THE GUIDEWIRE AND DIFFICULT TO REMOVE. THE BALLOON AND THE GUIDEWIRE WERE REMOVED AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623036 ↗
• MalfunctionSep 22, 2022Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE GUIDEWIRE WAS ALLEGEDLY STUCK AND DIFFICULT TO REMOVE. THE BALLOON AND THE GUIDEWIRE WERE REMOVED AS ONE UNIT. IT WAS FURTHER REPORTED THAT THE HUB OF THE CATHETER WAS BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15468591 ↗
• MalfunctionAug 5, 2022Difficult to Insert; Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Material Deformation; Difficult to Insert; Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE WAS ALLEGEDLY DIFFICULT TO REMOVE AND REINSERT. 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 15173066 ↗
• MalfunctionFeb 22, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PHYSICIAN TRIED TO REMOVE THE PTA BALLOON AFTER INFLATION BUT FELT A STRONG RESISTANCE AND DIFFICULT TO REMOVE FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE PHYSICIAN MANAGED TO REMOVE THE BALLOON AND COMPLETED THE PROCEDURE USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576902 ↗
• MalfunctionJul 24, 2019Retraction Problem; Device-Device Incompatibility; Material Deformation; Retraction Problem; Device-Device Incompatibility; Material Deformation

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL US14150515 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION, DEVICE-DEVICE INCOMPATIBILITY, AND A RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE MALE PATIENT'S AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824306 ↗
• MalfunctionJul 16, 2019Retraction Problem; Retraction Problem

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL US14150515 PTA BALLOON DILATATION CATHETERS ALLEGEDLY EXPERIENCED A RETRACTION PROBLEMS. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE ALLEGED MALFUNCTIONS EACH INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR ONE PATIENT. THE OTHER PATIENT WAS REPORTED TO BE MALE, AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8796523 ↗