Wallace 700/300/110Recalls & reported problems

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019315015373), received between Jun 29, 2017 and Jun 29, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Device Operates Differently Than Expected1
Patient-Device Incompatibility1

Patient problems

No Code Available1
Renal Failure1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryJun 29, 2017Patient-Device Incompatibility; Device Operates Differently Than Expected; Patient-Device Incompatibility; Device Operates Differently Than Expected
IT WAS REPORTED AFTER USE OF A WALLACE¿ VAGINAL RING PESSARY, THE PATIENT EXPERIENCED URETERAL OBSTRUCTION AND ACUTE POST-RENAL FAILURE. THE ADVERSE EVENTS WERE OBSERVED AFTER A CT SCAN, WHICH IS WHEN SIGNIFICANT DILATION OF A URETER WAS CONFIRMED ON BOTH SIDES. THE PESSARY WAS THEN REMOVED AND AN INDWELLING BLADDER CATERER WAS PLACED. THE PATIENT'S SERUM CREATINE WAS INCREASED 3.2MG/DL. AFTER THIS TREATMENT, THE PATIENT EXCRETED THE MAXIMUM VOLUME OF DILUTE URINE. THE NEXT MORNING, THE PATIENT'S SERUM CREATINE WAS DECREASED TO 0.8MG/DL. THE PATIENT THEN RECOVERED AFTER ONE DAY OF OBSERVATION. NO PERMANENT INJURY WAS REPORTED.
Patient problems: No Code Available; Renal Failure
MAUDE report 6678481 ↗

Device details

UDI-DI	`15019315015373`
Brand	Wallace
Model	700/300/110
Company	Icu Medical, 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	Not in Commercial Distribution
Record updated	Apr 17, 2025

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 and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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