ULTRASCORE US14150420Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741113734), received between Jan 14, 2020 and Jan 14, 2020 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2020Retraction Problem; Device-Device Incompatibility; Retraction Problem; Device-Device Incompatibility

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL US14150420 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEVICE-DEVICE INCOMPATIBILITY AND RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) MONTH OLD MALE PATIENT WAS (B)(6) KG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9587141 ↗