SonaStar MXA-D212Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841626100350), received between Dec 3, 2019 and Dec 3, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2019Material Fragmentation; Material Fragmentation

  THE CUSTOMER STATED PROBLEM, "DURING DR. (B)(6) HEPAPEXTOMY, THE TIP OF THE SONASTAR TIP DETACHED AND WAS FOUND LYING ON TOP OF THE PATIENTS LIVER. PRIOR TO THE TIP SEPARATION THE DOCTOR COMPLAINED OF NO SUCTION. AS PER REP [SALES REP] "THE PRODUCT WAS NOT SAVED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9406332 ↗