Mityvac 10008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888937003055), received between Mar 23, 2023 and Mar 23, 2023 — classified as 1 malfunction.

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

• MalfunctionMar 23, 2023Mechanical Problem; Mechanical Problem

  DETAILS REPORTED ON INCOMING (B)(4).ARE AS FOLLOWS: "WHEN PULLING, DOCTOR HAD A FEELING THAT CUP IS ABOUT TO BREAK (SOUND, FEELING IN HAND WHEN PULLING). THEY CHANGED THE CUP TO THE SAME KIND OF CUP. THAT CUP WAS FINE. NEVERTHELESS DELIVERY ENDED UP TO EMERGENCY C-SECTION. CHANGING THE CUP TOOK TIME AND THAT WAY EFFECTED TO DECISION." "PATIENT (MOTHER) SUFFERED 2000 ML BLOOD LOSS AND HAD BLOOD TRANSFUSION (2 UNITS) ONE DAY AFTER DELIVERY. SHE HAS RECOVERED AND BEEN DISCHARGED FROM HOSPITAL. MIDWIFE DIDN'T TELL ME BABY'S STATUS."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16600576 ↗