Berkeley Vacurette 21593ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925038004), received between Nov 25, 2019 and Nov 25, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 25, 2019Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem

  SURGEON REQUESTED 10MM CURVED VACURETTE CANNULA. THE APPROPRIATE SIZE PER PACKAGING WAS SELECTED AND OPENED. UPON INSPECTION, IT SEEMED TOO LARGE. FURTHER INSPECTION OF THE PACKAGING REVEALED THAT THE WRONG SIZE INDICATOR HAD BEEN PLACED INSIDE THE PACKAGING BY THE MANUFACTURER. THE ACTUAL SIZE OF THE CANNULA WAS 14MM. A SIZE 10MM CANNULA WAS THEN OPENED AND USED FOR THE PROCEDURE. PER THE CIRCULATOR, THE PACKAGE INSERT STATING SIZE AND WHAT SHE READS TO CHOOSE REQUESTED SIZE SHOWS THE SIZE AS 10MM. THE OUTER PACKAGING STATES THE SIZE AS 14MM. SHE REPORTED THAT THE INK COLOR FOR THE INSERT IS RED FOR THE 10MM AND 14MM. SHE SUGGESTED TO HAVE A DIFFERENT COLOR FOR EACH SIZE CANNULA FOR BETTER VISUALIZATION AND EASE IN OBTAINING THE DESIRED SIZE. THE SIZE ON THE OUTER PACKAGING IS ALSO DIFFICULT TO FIND AND WRITING IS VERY SMALL. CURRENT INVENTORY WAS ASSESSED AND THIS ONE CANNULA BEING REPORTED WAS THE ONLY FOUND WITH INCORRECT PACKAGING. CURVED VACURETTE CANNULA AND PACKAGING (INNER AND OUTER) SAVED FOR QUALITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9368754 ↗

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.