FDA Initiates Class I Recall of Stryker Pleural Drainage Devices

Gupta_Ford_Vinson_surgeryMedical devices are some of the greatest inventions of modern medicine and have helped countless sick individuals overcome painful conditions. Despite this, however, there are far too many instances in which a medical device manufacturer fails to ensure that its device is safe for its intended use. When this happens, the injured patients can bring a product liability claim against the device manufacturer to recover damages for their injuries. In some instances, plaintiffs can even successfully obtain punitive damages against the manufacturer, which are intended to punish a manufacturer whose conduct is found to be willful, reckless, and malicious and to serve as a deterrent for other manufacturers.

To prevail in a product liability claim, the plaintiffs must prove that the device was designed in an unreasonably dangerous manner or that the specific devices that the plaintiffs received suffered from a manufacturing defect that caused them to be unreasonably dangerous.

Although there are many ways to prove that a device bears an unreasonably dangerous design or a manufacturing defect, citing an FDA device recall can provide strong evidence. Recently, the U.S. Food and Drug Administration (“FDA”) initiated a Class I recall for Stryker’s pleural drainage device, which was developed to remove fluid or air from the pericardium space around the heart, or from the pleural cavity that provides protection to the lungs. A Class I recall is the most severe type of recall that the FDA can order.

According to the recall, the devices have a “reasonable probability” of causing serious adverse health conditions and have even led to death in some instances. In most cases involving adverse events, the medical professionals using the devices reported that the device breaks inside the pleural cavity while it is being inserted.

The announcement points to two specific instances in which medical professionals reported to Stryker that the device malfunctioned during a procedure and broke off inside the pleural cavity. In each instance, immediate medical intervention was necessary, and injuries and even deaths were reported.

The recall encompasses 34 of Strkyer’s devices distributed in the United States. These devices are labeled with the number G03974 and were produced between November 2009 and October 2011. At least 13 different states have been implicated in the recall, including California, New York, Wisconsin, and Florida. The devices in question were distributed between December 2009 and October 2011. Physicians have been advised to immediately discontinue using the recalled products and to return them to Stryker promptly.

If you or someone you love has suffered injuries as the result of a defective medical device, you may be entitled to compensation. Knowing how to bring a claim against a medical device manufacturer or whether you even have a viable claim can be incredibly daunting, especially when you are suffering from painful injuries. At Moll Law Group, our skilled team of defective medical device lawyers have represented clients throughout the nation, including in Illinois, Texas, Florida, and New York. Call us at 312-462-1700 or contact us online to set up your free consultation now.

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