Regulatory Focus™ > News Articles > 2019 > 10 > Another Class I Recall of Ethicon Surgical Staplers, FDA Says

Another Class I Recall of Ethicon Surgical Staplers, FDA Says

Posted 30 October 2019 | By Zachary Brennan 

Another Class I Recall of Ethicon Surgical Staplers, FDA Says

Following seven serious injuries and one reported death, the US Food and Drug Administration (FDA) announced a Class I recall, the most serious type of recall, of some of Ethicon’s Flex Endopath surgical staplers because they may contain an out of specification component within the jaw of the device that could lead to malformed staples.

Ethicon, a subsidiary of Johnson & Johnson (J&J), said that earlier this month it sent a letter to customers who purchased the affected staplers.

FDA added: “If a problem with the staple line is not recognized or is not adequately addressed, there is a potential risk of prolonged surgery, postoperative connection (anastomotic) leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.”

The recall follows another Class I recall of Ethicon surgical staplers in May, and both recalls are part of a growing body of concerns related to surgical staplers and implantable staples.

Last March, FDA sent a letter to health care providers after discovering more than 41,000 medical device reports that describe adverse events and deaths associated with the use of surgical staplers and staples for internal use between 1 January 2011 and 31 March 2018.

In April, FDA proposed to reclassify surgical staplers from class I (general controls) into class II (special controls) and Medtronic and J&J offered support for that reclassification.

Ethicon Recall

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