• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

iRadimed issues urgent field safety notice for some infusion pump syringe adapters

February 27, 2023 By Sean Whooley

IradimediRadimed (Nasadq:IRMD) issued an urgent medical device correction letter to warn of issues with some infusion pump syringe adapter sets.

The letter notifies customers of a potential issue with some 1057 Syringe Adapter Sets. The issue relates to the syringe venting function during use. This can lead to reduced flow with the MRidium infusion pump, resulting in subsequent inlet occlusion and alarm indication.

Winter Springs, Florida-based iRadimed designed the adapter set as a unique IV fluid administration set. It features a vented syringe adapter (disposable tubing) for fluid delivery while on iRadimed’s infusion pump.

The company received five customer complaints of an unexpected inlet occlusion alarm resulting in stopped infusion. None of these complaints were associated with injuries or death, according to a news release. iRadimed investigated the issue and uncovered a defective injection molded part. This defective part can limit the effectiveness of the syringe vent and result in this condition.

iRadimed estimates that the issue affects 0.4% of recently manufacture 1057 infusion sets. The company took voluntary action to maximize the safety of the device’s use with the knowledge of the FDA. It affects no other iRadimed infusion sets or disposables. The company expects no material financial impact from its voluntary action.

Filed Under: Business/Financial News, Drug-Device Combinations, Recalls, Regulatory/Compliance, Technology Tagged With: Iradimed

IN CASE YOU MISSED IT

  • Flat Medical partners with Mercury Medical on smart syringe distribution
  • Glucotrack to effect a reverse stock split
  • Medtronic unveils ‘MiniMed’ as name for soon-to-be separated Diabetes unit
  • Insulet, Marvel collab to unveil comic book hero with type 1 diabetes
  • Insulet rolls out new Omnipod 5 iPhone app for use with Dexcom G7

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS