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

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Medtronic initiates voluntary recall of Covidien Oridion Capnostream batteries

Medtronic initiates voluntary recall of Covidien Oridion Capnostream batteries

April 20, 2016 By Fink Densford

MedtronicMedtronic (NYSE:MDT) said today it is initiating a voluntary recall of battery packs used with its Covidien Oridion labeled Capnostream 20 and 20p patient monitors due to a defect causing an increased risk of thermal damage in the packs.

Capnostream monitors are external devices used to assess respiratory status and identify changes in breathing, the Fridley, Minn.-based company said, and are used in both clinical and home settings.

Medtronic said it has received 7 reports of thermal damage out of the 9,817 battery packs affected by the field action, with 1 report involving a fire that resulted in smoke inhalation and minor burns, according to a press release.

The voluntary recall affects battery packs with model numbers 016400 and 010520 manufactured by a contract manufacturer between April 2014 and February 2016.

The medtech giant sent a letter to customers with affected units along with a rework kit with full instructions for removal and disposal or recycling of the affected battery packs. Medtronic said it recommended customers use the Capnostream monitors on AC power with the pack removed until a replacement battery is available.

Medtronic said it identified a manufacturing change conducted by the 3rd party contract manufacturer as the root cause and is manufacturing new batteries to meet the original specifications with a new contract manufacturers, which will be supplied to affected customers when available.

The company said it contacted the FDA and other regulatory bodies to inform them of the issue.

Filed Under: Patient Monitoring, Recalls, Regulatory/Compliance Tagged With: Medtronic

More recent news

  • Breaking: Sequel to launch twiist automated insulin delivery system next month
  • Dexcom shares U.S. report on CGM benefits for type 2 diabetes
  • Data backs Medtronic MiniMed 780G for type 2, children as company seeks expanded indications
  • Endogenex data supports type 2 diabetes procedure
  • Ambu wins FDA clearance for first single-use cysto-nephroscope

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock 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

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

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