ULTRASCORE US14150330Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741113550), received between Jul 19, 2019 and Feb 20, 2024 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2024Deflation Problem; Failure to Advance; Device-Device Incompatibility; Deflation Problem; Failure to Advance; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE BELOW KNEE LESION, AFTER PASSING THE GUIDEWIRE, THE PTA BALLOON ALLEGEDLY COULD NOT BE PASSED THROUGH THE LESION. IT WAS FURTHER REPORTED THAT THERE WERE ISSUES DEFLATING THE DEVICE DURING THE PREVIOUS INFLATION. ADDITIONALLY, THE GUIDEWIRE WAS ALLEGEDLY DIFFICULT TO INSERT INTO THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738687 ↗
• MalfunctionNov 25, 2023Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18207600 ↗
• MalfunctionJan 10, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE SCORING WIRE OF THE BALLOON WIRE WAS ALLEGEDLY FOUND TO BE PEELED OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129005 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE, ANGIOGRAPHY DEMONSTRATED TARGET LESION STENOSIS. ATHERECTOMY, CUTTING/SCORING BALLOON(S) AND THROMBOLYSIS WERE USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 10981262 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY SEVEN MONTHS AND EIGHT DAYS POST INDEX PROCEDURE, ANGIOGRAPHY DEMONSTRATED TARGET LESION STENOSIS. PTA (NON DCB) AND ATHERECTOMY WERE USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 10798173 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY TWENTY THREE DAYS POST INDEX PROCEDURE, ANGIOGRAPHY DEMONSTRATED NEW LESION STENOSIS. PTA (NON DCB) WAS USED TO SUCCESSFULLY TREAT THE NEW LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Restenosis

  MAUDE report 10745925 ↗
• MalfunctionJul 19, 2019Retraction Problem; Failure to Advance; Device-Device Incompatibility; Retraction Problem; Failure to Advance; Device-Device Incompatibility

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL US14150330 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED FAILURE TO ADVANCE, 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 8809532 ↗