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

Medical Tubing and Extrusion

Medical tubing and extrusion technologies

  • Catheters
  • Components
    • Connectors
    • Needles and Injections
    • Seals
    • Tubing Components
  • Manufacturing
    • Coatings
    • Extrusions
    • Machining
    • Injection Molding
    • Insert molding
    • Tools
  • Materials
    • Advanced Materials
    • Silicone
  • Research & Development
  • Suppliers

Medtronic’s Covidien Palindrome and Mahurkar hemodialysis catheter recall is Class I

July 29, 2022 By Danielle Kirsh

medtronic-large-updatedMedtronic’s subsidiary Covidien issued a Class I recall of more than 1 million Palindrome and Mahurkar hemodialysis catheters.

Covidien issued the recall due to a catheter hub defect that will connect both extension catheters. The defect could leak within the hub of a chronic dialysis catheter, which can lead to mixing of the arterial and venous blood and lead to increased recirculation and poor dialysis and development of the thrombi and emboli.

Use of the recalled catheters may cause serious adverse health outcomes, including bleeding, surgical removal and replacement of the affected catheter, according to an FDA warning letter. There has been one complaint and no reports of death or injury related to the device.

Palindrome and Mahurkar catheters are implanted in patients and used in hemodialysis, aphaeresis and infusion.

The recall affects Palindrome and Mahurkar hemodialysis catheters manufactured between June 1, 2017 and April 1, 2022 with distribution dates of June 28, 2017 to May 11, 2022. There are 1,032,377 devices affected by the recall in the U.S. Specific lots involved in the recall can be found on the FDA database.

Medtronic issued an urgent medical recall letter to customers affected by the recall to inform them of the product issue and its potential health risks. The company recommends immediately quarantining and discontinuing use for the specific lots of chronic hemodialysis catheters. It also recommends identifying the potential contamination of fluid while flushing one extension tube to assess for the unanticipated simultaneous fluctuation of fluid in the adjacent extension tube.

Filed Under: Catheters Tagged With: covidien, medtronic

Primary Sidebar

DeviceTalks Tuesdays

DeviceTalks Tuesdays
MDO ad

Stay Current

Need Medical Tubing news in a minute?
We Deliver!

Medical Tubing + Extrusion newsletter get you caught up on all the mission critical news you need in medical tubing. Sign up today.

Enews Sign up

Sponsored Content

A new way to access scientific papers?

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website

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

Inv Logo

MASSDEVICE MEDICAL NETWORK

MassDevice
DeviceTalks
Medical Tubing & Extrusion
Medical Design & Outsourcing
MedTech 100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Souring
R&D World

Medical Tubing & Extrusion

Subscribe to our e-newsletter
Advertise with us
About
Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our Device Talks Tuesdays Discussion
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · 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.

Advertise | Privacy Policy | RSS