Serious blood clots may result from defective medical device

People in Nashville regularly depend on a variety of medical devices. They trust that these products are safe to use, particularly when they are administered by a physician. Sometimes, however, these devices contain dangerous defects that may result in serious injuries to patients. 

Medical device manufacturer Covidien is conducting a medical device recall for some lots of its peripheral infusion systems. While no injuries have yet been reported, the use of these defective medical devices could result in blood clots in patients’ lungs. Reports did not specifically state what types of medical treatments involved the use of these products.  

The problem with these devices is attributed to a manufacturing error in which some of the inflation ports were mislabeled. This improper labeling could lead physicians to deflate the device’s balloons in the wrong order.   

Those who have experienced adverse health effects after using this product are encouraged to report their injuries through FDA’s MedWatch Adverse Event Reporting Program. Physicians are advised to monitor patients who were treated with these recalled devices. 

These peripheral infusion systems were the subject of a December 2014 voluntary recall. In February of this year, however, these potential dangers of these defective devices led to their reclassification as an FDA Class 1 Recall.

When a defective medical product results in serious injuries, treatments can be both invasive and expensive, often with prolonged recovery periods. Depending on the situation, those who have been hurt by such products may be able to recoup some of their losses through a product liability lawsuit. If you are interested in this option, you may wish to consult with an attorney. 

Source:, “FDA Classifies Previous Covidien Field Action For Its Trellis-6 and Trellis-8 Peripheral Infusion Systems as a Class 1 Recall,” Feb. 12, 2015 

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