Assistant with StableSoft 3S 45051Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00699753450516), received between Feb 3, 2022 and Feb 3, 2022 — classified as 1 injury.

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 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.

• InjuryFeb 3, 2022Break; Material Fragmentation; Break; Material Fragmentation

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, PART OF THE RETRACTOR CAME OFF. PER FACILITY, A PLASTIC DOT CAME OFF THE PADDLE ONTO TO THE HEART AND WAS SEEN BY THE FIRST ASSISTANT NOTED A SMALL WHITE FOREIGN BODY IN THE SURGICAL FIELD ON THE HEART. THE FIRST ASSISTANT WAS ABLE TO VISUALIZE AND RETRIEVE THE SMALL OBJECT AS THEY WERE WEARING A PAIR OF MAGNIFYING SURGICAL LOUPES. PER CLINICIAN, THE FOREIGN OBJECT WAS IDENTIFIED AS POSSIBLY BEING A SMALL PIECE OF SILICONE OVER MOLDING FROM THE RETRACTOR. THE PRODUCT WAS NOT CHANGED OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13446467 ↗