PATH® 20070013Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684200700131), received between Apr 8, 2020 and Oct 28, 2021 — classified as 1 injury, 1 malfunction.

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

• MalfunctionOct 28, 2021Residue After Decontamination; Residue After Decontamination

  ALLEGEDLY, DEVICES HAD BLOOD WASTE FROM PREVIOUS OPERATIONS.

  Patient problems: Insufficient Information

  MAUDE report 12716492 ↗
• InjuryApr 8, 2020Break; Material Disintegration; Break; Material Disintegration

  ALLEGEDLY, THIS IS AN INSTRUMENT, THREAD DEBRIS WHERE LEFT IN THE PATIENT. THREADS FOUND POST OP ON X-RAY AND LEFT IN PATIENT. THE PHYSICIAN WAS NOT AWARE THE THAT THE INSTRUMENT HAD BROKEN UNTIL X-RAY WAS READ IN POST OP. THREADS BROKEN ON INSTRUMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9940894 ↗