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
    • 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

Recall: Mitral Valve Delivery System Failure Results in 9 Unplanned Surgeries

March 1, 2016 By U.S. Food and Drug Administration

Abbott has initiated a voluntary safety notice regarding the MitraClip Delivery System to reinforce the proper procedures used to operate and deploy the device. The company received a small number of reports involving MitraClip Delivery Systems where the user was unable to separate the implantable Clip from the delivery system. Presently, there are 3,534 devices on the market (1,288 in the United States and 2,246 outside the United States). Abbott has received nine Medical Device Reports of malfunction.

Abbott’s investigation determined that the delivery system’s “arm positioner” was not returned to the required neutral position by the operator during the deployment sequence, subsequently preventing the Clip from detaching. All of these cases (0.17% incidence) resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem. There was one patient death in these cases as a result of severe comorbidities following surgery.

The U.S. Food and Drug Administration (FDA) has classified this safety notice as a Class I Recall. Abbott is not removing product from commercial distribution. Abbott is requiring training of all MitraClip implanting physicians on the safety notice to ensure continued safe use of the device and is incorporating the safety notice’s deployment sequence in its Instructions for Use.

Commercial Clip Delivery Systems with lot numbers 50714U1 and greater are within the scope of this action. Individuals who have already had the device implanted are not affected by this action.

Customers with questions or concerns should contact their Abbott Vascular Representative or call the company at 1-800-227-9902.

The MitraClip Delivery System is a minimally invasive device used to treat people with degenerative mitral regurgitation (DMR) a condition involving a dysfunction of the heart’s mitral valve.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to Abbott and to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Related Articles Read More >

Johnson & Johnson Office of Digital Innovation Leader Peter Schulam
Imagining the future of cloud-connected medical devices with Johnson & Johnson leaders
Withings Body Scan
Withings plans launch for Body Scan smart scale platform
BinaxNow COVID-19 Ag Card
Time recognizes Abbott offerings among this year’s 100 best inventions
Koya Medical’s Dayspring device
Koya Medical reports positive early results in Dayspring lymphedema trial

DeviceTalks Weekly.

May 13, 2022
Our Pre-Post-DeviceTalks Boston episode, also MedtronicTalks replay with Gastro CMO Austin Chiang
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
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • 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. 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
    • 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