Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

Serious medical device recalls nearly doubled in Q2

August 8, 2017 By Chris Newmarker

medical device recalls FDAMedical device recalls at the Class I level were up 88% during the second quarter of 2017, and the major culprit was quality issues involving device part malfunctioning, according to a new report from Stericycle ExpertSolutions.

Quality played a significant role among the 15 serious medical device recalls during the second quarter, partly because it encompasses such a host of problems including failure to establish durability, approving products before they were ready, and poor quality of components.

There was also a noticeable uptick versus the previous quarter in pharmaceutical and food recalls that FDA labeled as Class I, according to the Stericycle report.

“Class I is the most critical type of recall, so to see increases across multiple industries where serious adverse consequences or death can occur is certainly concerning,” Michael Good, VP of marketing and sales at Stericycle ExpertSolutions, said in a news release.

Medical device recalls overall were down 3%, to 275 – making this year’s second quarter the lowest quarter for the number of device recalls over the past year. Recalled units, however, were up more than sevenfold in number – a 628% increase to nearly 67.6 million that made the second quarter higher than 15 of the last 18 quarters for the number of recalled units.

The average number of medical device units involved in Class I recalls is 876,076 per quarter so far in 2017, nearly triple the 310,158 average in 2016. The average was 276,233 in 2015.

Here are some of the notable FDA Class I recalls from Q2 2017:

  • FDA labels Vascular Solutions Venture catheters recall as Class I

  • FDA updates on Getinge/Datascope IABP recall, labels as Class I

  • FDA labels Zimmer Biomet SpF spinal fusion stimulator recall as Class I

  • Deaths prompt Abbott recall of Thoratec HeartMate II controllers

  • Abbott recalls select heart catheters over balloon sheath issues

  • FDA labels Philips Respironics V60 ventilator recall as Class I

  • FDA labels Medtronic HVAD splice kit recall as Class I

  • Medtronic updates on HVAD system controller recall, labeled as Class I

  • Medtronic’s StrataMR Recall labeled as Class I

  • Merit Medical recalls Prelude sheath introducer over tip separation issues

[Want to stay more on top of MDO content? Subscribe to our weekly e-newsletter.]

Associate editor Fink Densford contributed to this story.

You may also like:

  • medical device value design healthcare medtech
    3 steps to create value with your medical device
  • binoculars at sunset medtech startup
    4 top regulatory issues to watch in 2017

About The Author

Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.

Comments

  1. William K. says

    August 14, 2017 at 2:35 pm

    Providing the required level of quality is never simple and easy, and so it is natural that there will be failures. Of course not all regard the quality efforts as a cost reduction operation. But given the cost and liability issues associated with the cause for recalls, maintaining adequate quality is indeed a means of reducing expenses. AND it is a good sales tool, being able to state that ” we never have been recalled.”

Related Articles Read More >

A photo of an FDA employee in the FDA Life Sciences Laboratory I in Building 64, which houses the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health.
Device developers must take action as experts leave FDA
This is the logo of MedTech Innovator.
MedTech Innovator announces 65 startups for its 2025 cohort
This is the logo of the U.S. Food and Drug Administration or FDA.
FDA rolls out ‘Elsa,’ a generative AI tool to boost efficiency across the agency
Proactive IP strategy to navigate your medtech startup through uncertain times
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

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

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 our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 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
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe