Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • Subscribe to Print Magazine
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Medtronic blood pump recall is serious

April 20, 2021 By Nancy Crotti

Medtronic Bio Console 560 system

Medtronic Bio Console 560 system (Image from Medtronic)

Medtronic is recalling a blood pump that can stop during cardiopulmonary bypass surgery due to electrical failure.

The Bio-Console 560 extracorporeal blood pumping console is used to pump and return blood to a person during bypass, a procedure that temporarily takes over the function of the heart and lungs. The cardiopulmonary bypass procedure provides both circulatory and breathing support to a person whose heart and lungs are too weak to pump enough blood to the rest of the body.

In cases where the pump stopped, or the interface went blank, users had to operate the pump using a hand crank until the device restarted or could be replaced by a backup unit, according to the FDA. Other issues observed by users include the interface going blank, smoke coming from the device and a burning odor during use, the agency said.

If the pump stops, patients could experience:

  • Insufficient blood flow potentially leading to organ dysfunction.
  • Blood clots potentially leading to low blood pressure.
  • Reversible or irreversible neurological dysfunction.
  • Death.

Nine complaints have been reported about this device issue, including three injuries, the agency said. No deaths have been reported, but the FDA declared the recall Class I, its most serious recall classification.

Medtronic issued the recall on March 3, 2021, asking distributors and customers to identify potentially affected devices and use unaffected Bio-Console 560 devices, if available, until a company technician can repair the problem. Medtronic distributed the pumps from April 1, 2019, through Feb. 12, 2021.

 

Related Articles Read More >

A lateral flow assay test for measuring COVID-19 immunity
COVID-19 immunity test developers at MIT seek diagnostic manufacturer
GE Healthcare image illustrating contrast media uses
GE Healthcare picks AI imaging startups for inaugural Edison Accelerator
Boston Scientific whistleblower launches corruption investigation
A portrait of Cathy Burzik, CEO of CFB Interests
5 essential leadership lessons from Cathy Burzik for medtech’s next generation of women leaders

DeviceTalks Weekly.

August 5, 2022
DTW Medtronic's Greg Smith lays out supply chain strategies
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

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.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

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
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. 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 LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • Subscribe to Print Magazine
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech