Covidien Recalls Surgical Staples After 3 Deaths

//Covidien Recalls Surgical Staples After 3 Deaths

Covidien Recalls Surgical Staples After 3 Deaths

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.

 

By | 2012-01-18T15:16:01+00:00 January 18th, 2012|Media Reports|4 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

4 Comments

  1. Handyman January 18, 2012 at 6:17 pm - Reply

    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?

    • Jane Akre January 18, 2012 at 9:57 pm - Reply

      That is an excellent question… we need an answer! MAUDE- time to revisit!

  2. DJ January 18, 2012 at 9:26 pm - Reply

    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 January 14, 2013 at 6:12 am - Reply

    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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