Milex MXPGE2-1/4Recalls & reported problems

Coopersurgical, Inc. · Gellhorn Flexible Pessary; 2 1/4" (57mm) · Class 2

Adverse event reports: 2
Deaths reported: 1
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888937006711), received between Nov 22, 2020 and May 27, 2025 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Too Rigid or Stiff1
Use of Device Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1
Rectovaginal Fistula1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

DeathMay 27, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE GELHORN PESSARY CREATED A HOLE BETWEEN THE PATIENT'S VAGINA AND THEIR RECTUM WHICH ALLOWED STOOL TO PASS THROUGH AND OUT OF THE VAGINAL OPENING. PATIENT IS SCHEDULED FOR SURGERY TO CORRECT THE FISTULA. UPDATE: JUNE 15, 2025: THE DANISH MEDICINE AGENCY HAS BEEN INFORMED FROM THE HEALTHCARE FACILITY THAT THE PATIENT INVOLVED IN THE INCIDENT HAS PASSED AWAY.
Patient problems: Rectovaginal Fistula
MAUDE report 22088946 ↗
MalfunctionNov 22, 2020Material Too Rigid or Stiff
THE PESSARY IS TOO STIFF. GELLHORN PESS FLEX 2 1-4 MXPGE2 1-4 E-COMPLAINT-(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10881831 ↗

Device details

UDI-DI	`00888937006711`
Brand	Milex
Model	MXPGE2-1/4
Company	Coopersurgical, Inc.
Product code	HHW · Pessary, Vaginal
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 28, 2024

Device type (GMDN): Pelvic-organ-supporting pessary

A device made of rubber or soft plastics designed for insertion into the vagina to hold the uterus, bladder and/or rectum in place and help prevent prolapse (falling or sliding of the organ from its normal position into the pelvic cavity), either as a permanent or temporary treatment; it is not dedicated to bladder-only support. It is available in a variety of shapes (e.g., rings, stems) and sizes; it may be fitted for each woman individually. This is a reusable device after appropriate cleaning.

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All Pessary, Vaginal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.