ULTRASCORE US14150310Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741113505), received between Oct 13, 2020 and Mar 19, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA IPSILATERAL PUNCTURE FOR SUPERFICIAL FEMORAL ARTERY TREATMENT, THE BALLOON ALLEGEDLY RUPTURED AT 6 BAR. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928905 ↗
• MalfunctionOct 31, 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 ANTERIOR TIBIAL ARTERY VIA AN IPSILATERAL ANTEGRADE APPROACH, THE GUIDEWIRE ALLEGEDLY FAILED TO BE INSERTED INTO THE SHEATH. IT WAS FURTHER REPORTED THAT THE CONNECTION PART OF THE HUB WHICH MADE OF RUBBER MATERIAL IN GRAY WAS ALLEGEDLY FOUND MISALIGNED. REPORTEDLY THE GUIDEWIRE ALLEGEDLY HAD DIFFICULTY REMOVING FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15697879 ↗
• InjuryJan 7, 2021Adverse 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 FIVE MONTHS AND EIGHT DAYS POST INDEX PROCEDURE, ANGIOGRAPHY DEMONSTRATED TARGET LESION AND TARGET VESSEL- NON TARGET 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 11129012 ↗
• InjuryOct 13, 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 SIX WEEKS POST INDEX PROCEDURE, ANGIOGRAPHY DEMONSTRATED TARGET LESION STENOSIS. ATHERECTOMY AND CUTTING/SCORING BALLOON(S) WERE USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 10671071 ↗