Mityvac 10004Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888937003031), received between Aug 22, 2024 and Aug 22, 2024 — classified as 1 injury.

4 other recalls cover devices cleared under the same FDA submission (K011532); 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.

• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA MEDWATCH REPORT THAT WAS FOUND IN THE MAUDE DATABASE: FAILED VACUUM EXTRACTION FOR DELIVERY OF NEWBORN RESULTING IN A LARGE HEMATOMA. ALLEGEDLY, THE COMPANY NOTIFIED THE ORGANIZATION THAT THE ITEM WAS BACK-ORDERED AND IT WAS ACCEPTABLE TO USE AN OUTDATED ITEM. 1216677-2024-00044 10004 PEARL CUP 2024-08-0000184.

  Patient problems: Hematoma

  MAUDE report 20028946 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011532. One submission often covers many models, so check the product and lot details in each record.

• Z-1887-2008 · Jan 16, 2008 · Terminated
  M-Style Mushroom Cup Vacuum Assisted Delivery System used with hand pump (Ref: 10007LP). Product is intended to assist a clinician in the delivery of an infant during childbirth
• Z-1889-2008 · Jan 16, 2008 · Terminated
  Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System (Ref: 10057). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated f
• Z-1888-2008 · Jan 16, 2008 · Terminated
  M-Style Cup with Universal Vacuum Release (UVR) used with wall suction, Vacuum Assisted Delivery System (Ref: 10015LP). Product is intended to assist a clinician in the delivery o
• Z-0005-05 · Aug 17, 2004 · Terminated
  Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047