Ethicon has issued multiple Class 1 recalls for surgical staplers due to a risk of severe injury or death to patients.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Ethicon surgical stapler induced injury cases in all 50 states. If you or somebody you know was injured when a surgical stapler malfunctioned, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Surgical Staplers Linked to 9,000+ Injuries & Deaths Since 2011
In March 2019, the FDA analyzed over 41,000 surgical stapler incidents since 2011. The incidents included 366 deaths, over 9,000 serious injuries, and over 32,000 malfunctions. Some of the most common problems include:
- opening of the staple line or malformation of staples
- difficulty in firing
- failure of the stapler to fire the staple
- misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue).
What is the Risk?
Stapler malfunctions or misuse may result in prolonged surgical procedures or unplanned, additional surgical interventions, which may lead to other complications, such as:
- fistula formation
- tearing of internal tissues and organs
- increased risk of cancer recurrence
Ethicon Recalls Echelon Flex Surgical Staplers
October 2019 — Ethicon issued a Class 1 recall for over 8,000 Echelon Flex™ Endopath® Surgical Staplers due to a risk of serious injury or death. One death and 7 serious injuries were reported as of October 3, 2019. The problem is that the staplers may fail to completely form a staple due to an out-of-specification part in the jaw of the device. The risks include prolonged surgery, postoperative connection (anastomotic) leak, hemorrhage, hemorrhagic shock, additional surgical intervention, and death.
Ethicon Recalls Endo-Surgery Intraluminal Staplers
May 2019 — Nearly 100,000 Ethicon staplers were recalled because they can misfire and cause severe injury or death to patients undergoing gastrointestinal surgery.
The FDA has issued a Class 1 Recall for 2 types of surgical staplers manufactured by Ethicon, Inc. because they can malfunction and cause severe injury or death to patients.
The recalled Ethicon staplers can cause severe injury or death to patients, including:
- The need for permanent ostomy “bag”
- Life-long nutritional and digestive issues
- Leak in the closure (anastomotic leak)
- Additional surgeries
- Need for additional closures (anastomoses)
- Need for antibiotics
- Additional imaging studies
At least 2 people were injured due to misfiring of the recalled staplers. One patient needed additional resection of the middle rectum and another patient needed additional resection of the lower rectum.
Surgeons use Ethicon Endo-Surgery Intraluminal Staplers in the gastrointestinal tract for creating connections between structures (anastomoses) in surgical procedures. The recall affects surgeons who perform gastrointestinal surgeries and patients, including patients with colorectal cancer and bariatric surgery patients.
The recall involves approximately 92,496 Endo-Surgery endoscopic and non-endoscopic staplers with adjustable height staples.
The recalled products have codes CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, ECS33A. They were manufactured between March 6, 2018 and March 6, 2019, and distributed between March 15, 2018 and March 8, 2019.
Do I have an Ethicon Surgical Stapler Lawsuit?
The Schmidt Firm, PLLC is currently accepting Ethicon stapler induced injury cases in all 50 states. If you or somebody you know was injured when a surgical stapler malfunctioned, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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