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:
- DUET6048, and