• 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 » Covidien discontinues surgical staples following patient injuries, deaths

Covidien discontinues surgical staples following patient injuries, deaths

August 22, 2012 By MassDevice staff

Covidien Duet TRS surgical stapler

Covidien (NYSE:COV) discontinued certain Duet TRS single-use surgical stapling systems following reports of patients deaths and injuries.

The medical device company cut the Duet TRS Universal Straight and Articulating Single-Use Loading Units following a single report linking the tissue reinforcement devices to a post-operative injury, according to a press release.

That’s in addition to the 13 serious injuries and 3 patient deaths that earlier this year spurred a recall and FDA warnings of possible mismanagement of the recall.

In January Covidien recalled the entire production lot of its Duet TRS single-use heads for thoracic surgery, modifying the product’s instructions and warning against use in thoracic procedures.

"The company has concluded that Duet TRS has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, post-operative complications," Covidien reported at the time.

The Mansfield, Mass.-based device maker had also placed a hold on its global Duet TRS inventory to conduct the relabeling.

In June the FDA asked Covidien to defend its management of the recall, chiding the device maker for its lack of sufficient documentation and delayed response to adverse event reports, which were first noted more than 2 year prior to the recall.

FDA inspectors conducted an investigation of Covidien’s North Haven, Conn., facility between Jan. 13 and Feb. 9, concluding that the company "failed to document investigations into deaths and serious injuries" that spurred the safety warnings for the Duet TRS devices, which were 1st issued in Japan in March 2011.

That recall and the new notice affect 8 models of straight and articulating Duet cartridges, which are endoscopic stapling systems with preloaded tissue reinforcement material. The cartridges attach to GIA universal stapler handles.

"The company has concluded that Duet TRS may have the potential to injure adjacent anatomical structures, which may result in life threatening post-operative complications," according to the new statement.

To date Covidien has sold more than 540,000 units worldwide, according to a press release. The company sold less than $50 million worth of the devices in the 9 months ended June 29, 2012, according to a related SEC filing.

Discontinuing the products line is going to hit Covidien’s bottom line, lowering 4th quarter earnings per share by "several cents," the company noted.

Covidien has been the subject of a string of recent recalls, including one announced earlier this week for certain grounding pads contained in ablation device kits after at least 4 patients experienced “serious injuries, burns at the pad site.”

Earlier this month Covidien also  recalled certain lots of its cuffed Shiley tracheostomy tubes after receiving reports that the devices malfunctioned during patient ventilation.

Last month the Natick, Mass.-based medical device maker issued a renewed U.K. warning on potential battery defects in certain mobile ventilators used primarily by patients in their homes.

Earlier in July the FDA issued a safety alert after receiving reports of more than 100 adverse events, including 9 patient deaths, that may have been caused by Onyx brain blood vessel plugs made by Covidien subsidiary ev3 Inc.

COV shares lost 2% today, trading at $55.28 as of about 11:50 a.m.

Filed Under: News Well, Recalls, Surgical Tagged With: Covidien

More recent news

  • Neuralink files to raise $649M in new equity offering
  • BofA: Surgical robot remanufacturing not a major setback for Intuitive
  • InspireMD wins CE Mark approval for CGuard Prime
  • Philips reports first cases for VeriSight Pro 3D ICE catheter in Europe
  • Ceryx Medical raises $15M to support bioelectronic pacemaker

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