Gyrus ACMI 003997-901Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925037908), received between Mar 22, 2024 and Mar 22, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K171440); they may or may not involve this specific model.

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.

• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED, THE GAUZE SACK WITH O-RING 10 PK HAD A MISSING O-RING. THE ISSUE WAS AN OUT OF BOX FAILURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959113 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171440. One submission often covers many models, so check the product and lot details in each record.

• Z-0078-2023 · Sep 16, 2022 · Open, Classified
  Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.