Medical Device Recall: Fatal Complications with the Covidien Duet TRS in Chest Surgery
Covidien Issues Medical Device Recall of Duet TRS Product
As Allison Connelly reports for Bloomberg Businessweek, medical device maker Covidien has issued a voluntary recall of its Duet TRS device, which has been linked to 13 injuries and three deaths in patients who underwent chest surgery.
The Duet TRS medical device is a "tissue reinforcement product" used with medical staplers in laparoscopic surgery.
Here's the problem with the Duet TRS: It can cause damage to "adjacent anatomical structures" in the chest cavity, according to Covidien.
In other words, the Duet TRS appears to cause damage to patients' heart and lungs.
500,000 Duet TRS Units Sold Worldwide
According to a press release issued by Covidien, half a million Duet TRS units have been sold.
Many of these units are intended to be used in thoracic surgery, which risks injury or death to other patients, excluding those who have already been injured or killed. Covidien has issued its voluntary recall in an effort to protect patient safety.
The company says, "These steps are consistent with our belief that patient safety is a commitment that cannot be compromised. Patient safety is our first obligation."
Liability for Defective Medical Devices
The voluntary recall of a defective medical device was the responsible thing for Covidien to do. The recall will involve relabeling the Duet TRS to indicate use in surgeries other than chest surgery (indeed, the Duet TRS is not being recalled for other uses) as well as put surgeons and health care providers on alert.
With company-reported 2011 revenue of more than 11 billion, Covidien is among the group of larger medical device manufacturers like Medtronic, which also happens to have had recent legal trouble with its Infuse bone graft medical device.
Large medical device manufacturers have an obvious need to protect the bottom line and their reputations.
And while voluntary recalls are good for "patient safety," they do nothing for those who have already been seriously injured or even killed because of a defective medical device. In those cases, injured patients (or the families of loved ones who died) should consider a claim for negligence for defective medical devices.