Covidien Recalls Surgical Staples After 3 Deaths

Jan 18th, 2012 | By | Category: Media Reports

Covidien Duet from website

January 16, 2012 ~ Medscape Medical News (here) reports that medical device maker Covidien is voluntarily recalling surgical staples used in endoscopic thoracic surgery after three deaths were linked to the device. In addition to the three deaths, there were 13 serious injuries associated with the Duet TRS single-use cartridges which have the potential to injure adjacent structures in the thorax which may be life-threatening.

Under law, a medical device maker is required to alert the Food and Drug Administration (FDA)when it receives reports of complications, injuries and death associated with its product. The death and injury reports were very recent, said the company in a press release (here).

The Covidian implantable staple is a Class II medical device under the FDA designation. Premarket approval is not necessary only a 510(k) application claiming the device is substantially equivalent to another device on the market.

See a 510 letter here:

The company has sold more than 500,000 units. The recall does not affect staples used for other parts of the body such as abdominal surgery.

The recall applies to the following 8 versions of the cartridge:

  • DUET4535,
  • DUET4535A,
  • DUET4548,
  • DUET4548A,
  • DUET6035,
  • DUET6035A,
  • DUET6048, and
  • DUET6048A.

 

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4 Comments to “Covidien Recalls Surgical Staples After 3 Deaths”

  1. Handyman says:

    I guess that’s what blows me away about mesh….this stuff caused 3 deaths and only 13 serious injuries and they voluntarily recall it. Does anyone have the latest totals on deaths and adverse affects of mesh?

  2. DJ says:

    As a nurse, it’s very disturbing when one sees how many 510(k) medical products (no pre marketing testing or post marketing follow-up) are causing serious injury and death to the very patients that these devices are supposed to help. At least it appears that Covidian has acted in a morally correct and ethical way by removing their product from market as soon as they recognized a problem with it. That’s a lot more than I can say for many other medical device companies (TVM, for example), whose denials and inactions only harm more people.

  3. Jaque says:

    Coviden made my mesh, it was pulled off the market because of erosion and vaginal infection. I have not been able to sit down since 2005 without extreme pain. I have never been able to find out when they pulled it off. I now have serious complications with no help. I continue to suffer.

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.