• 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

The worst catheter-based device recalls of 2020

February 19, 2021 By Danielle Kirsh

medtronic-large-updatedMedtronic: Rashkind balloon septostomy catheters

Medtronic initiated a recall of its Rashkind balloon septostomy catheters in August last year. The FDA designated the recall Class I on Nov. 3.

The recall involved 142 devices, which are designed to create an atrial septal defect or enlarge an existing atrial septal defect to treat congenital heart defects. The devices have quality issues that could lead to the device breaking, separating or failing during use. Adverse events could cause serious health consequences, including damage to blood vessels and death.

Fridley, Minn.-based Medtronic had two reported injuries and one death related to the device, according to a Nov. 3 FDA warning letter.

Medtronic has stopped making and distributing the Rashkind balloon septostomy catheters for reasons unrelated to the recall.

Catheters involved in the recall were distributed between May 28, 2018 and Aug. 28, 2020.

“To date, all customers have confirmed notification of the issue and have been asked to return all unused inventory to Medtronic. Medtronic is committed to patient safety and has communicated this information to the appropriate regulatory agencies,” a Medtronic spokesperson told Medical Tubing + Extrusion in an email.

Next >>

Pages: Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10

Filed Under: Catheters, Implants Tagged With: Abbott Vascular, Applied Medical, Arrow International, Boston Scientific, Cook Medical, Endologix, LeMaitre Vascular, medtronic, teleflex, Vascular Solutions

Primary Sidebar

DeviceTalks Tuesdays

DeviceTalks Tuesdays

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.
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
Tweets by MedTechDaily
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

Footer

Inv Logo

MASSDEVICE MEDICAL NETWORK

MassDevice
DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing

Medical Extrusion & Tubing

Subscribe
Advertise with us
About
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn Follow us on YouTube

Copyright © 2021 · 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