ULTRASCORE US14150220Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741113338), received between Oct 16, 2019 and Mar 11, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 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 FOURTEEN DAYS POST INDEX PROCEDURE, ANGIOGRAPHY DEMONSTRATED TARGET LESION AND VESSEL STENOSIS. A PTA (NON DCB) WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 11461930 ↗
• MalfunctionOct 16, 2019Retraction Problem; Device-Device Incompatibility; Retraction Problem; Device-Device Incompatibility

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL US14150220 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED RETRACTION PROBLEMS AND DEVICE-DEVICE INCOMPATIBILITY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. THE MALE PATIENT IS 77 YEARS OLD AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9200124 ↗