FDA Announces Class I Recall of Defective Surgical Stapler and Staples
In April 2019, we discussed the U.S. Food and Drug Administration’s (FDA) findings of serious injuries and even deaths related to malfunctioning surgical staplers and misapplied surgical staples. In May 2019, the FDA announced that Ethicon was recalling its circular staplers due to their tendency to misfire and to fail to completely form staples, both of which can put patients at risk. The recall is a Class I recall, which is the most serious of all recalls.
Affected products and identifying information include:
- Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and
- Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples
- Product Codes: CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, ECS33A
- Manufacturing Dates: March 6, 2018 to March 6, 2019
- Distribution Dates: March 15, 2018 to March 8, 2019
- Devices Recalled in the U.S.: 92,496
- Date Initiated by Firm: April 11, 2019
The affected staplers are used by surgeons to connect structures in patients’ gastrointestinal tracts during surgical procedures. When the staplers misfire or the staples are misapplied, patients can experience severe and even fatal complications, including sepsis, bleeding, and lifelong nutritional and digestive issues. They also may require revision surgeries, powerful antibiotics, and even permanent ostomy bags.
Patients at risk from the defective staplers include anyone who had or may undergo gastrointestinal surgery, including patients with colorectal cancer and bariatric patients. If you or someone you love was injured by a surgical stapler or staples, call your doctor right away and get in touch with the defective medical product lawyers at Ferrer, Poirot & Wansbrough. We want to help you get the compensation you deserve.