Echelon Flex™ Endopath® Stapler Recalled Due to Deaths

Echelon Flex™ Endopath® Stapler Recalled

According to bloomberg.com, Johnson & Johnson has issued a recall of surgical staplers (ECHELON FLEX™ ENDOPATH® Staplers) following reports that seven individuals sustained serious injuries and one died, per the United States Food and Drug Administration (FDA).

The device, manufactured by Johnson & Johnson’s Ethicon unit, is used to cut and staple tissue back together at the same time during a surgical procedure. The issues with the device stem from a part that has caused malformed staples to not properly close incisions, the FDA said in a statement. This has led to leakage, bleeding, and additional surgeries to repair the initial incision.

As a result of the reported adverse effects of the surgical stapler, the FDA issued a Class I recall, which is the most serious category that is only declared when there is a significant risk of bodily harm or death.  The FDA did not indicate whether the injuries and death associated with the use of the surgical stapler were associated with the malfunctioning of the device.

Johnson & Johnson has faced over 100,000 lawsuits asserting that their products, including opioids, surgical devices, drugs, and baby powder, caused harm to patients.  In response to these lawsuits, the company has defended itself by asserting that its products are safe.  However, the mounting lawsuits against the company have begun to concern investors. In fact, the shares of Johnson & Johnson were recently down by 0.08%.

The recall is applicable to 8,256 staplers that were distributed in August and September of this year.  When contacted, Johnson & Johnson did not respond to a request for comment.