ACS EVHD34CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191072209658), received between Oct 10, 2024 and Oct 10, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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.

• MalfunctionOct 10, 2024Contamination; Contamination

  FOREIGN DEBRIS WAS FOUND IN THE FOLD OF THE DRAPE WHICH WAS WITHIN ACS CONVENIENCE KIT. THE DEBRIS WAS DISCOVERED WHILE PATIENT WAS UNDER ANESTHESIA BUT BEFORE INCISION. THE STERILE FIELD WAS DEEMED CONTAMINATED. THERE WAS A SIGNIFICANT DELAY WHILE THE ROOM WAS CLEANED, AND A NEW STERILE FIELD WAS SET UP WITH NEW SUPPLIES AND INSTRUMENTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20421015 ↗