November 1, 2019 — Ethicon recalled Echelon Flex™ Endopath® surgical staplers because they may fail to completely form staples.
The FDA designated it a Class 1 recall due to the life-threatening risks to patients. Ethicon reported 7 serious injuries and 1 death linked to the recalled staplers as of October 3, 2019.
Ethicon warned that an out-of-specification part in the jaw of the stapler may result in failure to completely form staples.
If a problem with the staple line is not recognized or is not adequately addressed, it can result in life-threatening injuries or death to a patient during surgery.
The potential risks include a prolonged surgery, postoperative connection (anastomotic) leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death, according to Ethicon.
Ethicon recalled four different versions of the stapler with product codes EC60A, PCEE60A, PLEE60A and PSEE60A.. The recall includes 8,256 staplers in the U.S. that were distributed between August 1, 2019 and September 26, 2019.
The recalled staplers may be used during open surgery or minimally-invasive surgeries, including gynecologic, urologic, thoracic, pediatric, and general surgeries, according to the FDA.
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