Portex 100/199/060Recalls & reported problems

All models of Portex (409)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019315022302), received between Aug 23, 2023 and Aug 23, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Device Markings/Labelling Problem1

Patient problems

Insufficient Information1

Recent adverse event reports

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

MalfunctionAug 23, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE DEVICE IS MARKED 6.0, BUT IS MARKED 6.5 ON THE SURFACE OF THE PRODUCT. PATIENT INVOLVEMENT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17608010 ↗

Device details

UDI-DI	`15019315022302`
Brand	Portex
Model	100/199/060
Company	Icu Medical, Inc.
Product code	BTR · Tube, tracheal (w/wo connector)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 17, 2025

Device type (GMDN): Conceptive cervical cap, reusable

A flexible device designed to promote conception, either by serving as a container to introduce semen into the cervix, or by acting as a cervical cup that allows sperm to be held in place for easier access to the cervical os. It is a plastic device that is typically larger, but shallower, than a contraceptive cap. The device is used to aid conception in couples who have experienced difficulties due to low sperm counts, reduced sperm motility or a hostile vaginal environment; and also for self or assisted insemination. This is a reusable device.

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Shiley 18770
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Shiley 18880
Covidien LP · Tube, tracheal (w/wo connector)
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Shiley 18780
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Shiley 18770S
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Shiley 18780S
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All Tube, tracheal (w/wo connector) 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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