Portex 4924-25Recalls & reported problems

All models of Portex (409)

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

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20351688051704), received between Aug 31, 2022 and Mar 28, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (3 reports).

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

Insufficient Flow or Under Infusion3
Infusion or Flow Problem2

Patient problems

No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 28, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THE MEDICATION IN THE TRAYS DIDN'T WORK. 4 DIFFERENT ANESTHESIOLOGIST USED THE SAME LOT ON 4 DIFFERENT PATIENTS AND NONE PROVIDED PAIN CONTROL. THE PATIENTS HAD TO RECEIVE ANOTHER TYPE OF ANESTHESIA FOR THEIR PROCEDURES. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16632666 ↗
MalfunctionAug 31, 2022Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem
IT WAS REPORTED THAT THE MEDICATION IN THE TRAYS DIDN'T WORK. 4 DIFFERENT ANESTHESIOLOGIST USED THE SAME LOT ON 4 DIFFERENT PATIENTS AND NONE PROVIDED PAIN CONTROL. THE PATIENTS HAD TO RECEIVE ANOTHER TYPE OF ANESTHESIA FOR THEIR PROCEDURES. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15327000 ↗
MalfunctionAug 31, 2022Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem
IT WAS REPORTED THAT THE MEDICATION IN THE TRAYS DIDN'T WORK. 4 DIFFERENT ANESTHESIOLOGIST USED THE SAME LOT ON 4 DIFFERENT PATIENTS AND NONE PROVIDED PAIN CONTROL. THE PATIENTS HAD TO RECEIVE ANOTHER TYPE OF ANESTHESIA FOR THEIR PROCEDURES. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326907 ↗

Device details

UDI-DI	`20351688051704`
Brand	Portex
Model	4924-25
Company	Icu Medical, Inc.
Product code	MIA · NEEDLE, SPINAL, SHORT TERM
Class	Class 2
FDA submission	K983858
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): Spinal needle, single-use

A sharp bevel-edged, hollow tubular instrument designed for short-term use to withdraw a sample of cerebrospinal fluid (CSF), assist introduction of a spinal guidewire or catheter (e.g., lumboperitoneal shunt, intrathecal catheter), and/or deliver contrast media and/or anaesthetic or analgesic agents intrathecally (subarachnoid) or into a vertebral disc, either directly or using the needle-through-needle technique. It is typically fenestrated, spring-tipped, and made of metal and/or plastic materials; some types may be semi-rigid and include a stylet for support during handling. This is a single-use device.

Other NEEDLE, SPINAL, SHORT TERM devices

Medline DYNJTS4301
Medline Industries, Inc. · NEEDLE, SPINAL, SHORT TERM
1 report

All NEEDLE, SPINAL, SHORT TERM 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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