Ethicon Echelon Stapler Recall
October 31, 2019 - Ethicon Inc. on Wednesday issued a Class I Recall for its Echelon Flex Endopath Staplers due to a defective component which could lead to malformed staples, or staples that fail to close completely after use, according to the FDA. This problem may cause adverse health complications, including:
- Prolonged surgery
- Post-operative connection (anastomotic) leak
- Hemorrhagic shock
- The need for additional surgical intervention
FDA said it is aware of at least 7 severe injuries -- including 1 death -- associated with the recalled Ethicon Echelon Staplers. Products affected by the recall include:
- ECHELON Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter (EC60A)
- ECHELON Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter (PCEE60A)
- ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 44cm Shaft Length (PLEE60A)
- ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 34cm Shaft Length (PSEE60A)
Endo Surgical Stapler Recall
May 17, 2019 - The U.S. Food & Drug Administration (FDA) has issued a Class I Recall for a pair of surgical stapler devices manufactured by Ethicon, Inc. (a subsidiary of Johnson & Johnson), for various defects which can increase the risk of severe injury or even death to patients undergoing treatment with the products.
Class I Recalls are reserved for “situations in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death,” according to the FDA.
This recall affects approximately 92,496 Endo-Surgery endoscopic and non-endoscopic staplers with adjustable height staples with product codes CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A and ECS33A. The surgical staplers were manufactured between March 6, 2018 and March 6, 2019, and distributed between March 15, 2018 and March 8, 2019, FDA said.
What are Ethicon Surgical Staplers Used For?
Ethicon Endo-Surgery endoscopic staplers are designed for use in the gastrointestinal tract to create anastomoses during surgical procedures, FDA said.
Surgical Stapler Complications
Potential risks from misfired staplers include:
- The need for permanent ostomy-bags
- Irreversible nutritional and digestive problems
- Leaks in closures
- Revision surgeries
- Follow-up closures
- The need for additional imaging studies
- And more
Also read: Defective Surgical Stapler Claim
Can I File a Class Action?
Although Schmidt & Clark, LLP, is a nationally recognized class action firm, we have decided against this type of litigation when it comes to Ethicon Surgical Staplers. Our lawyers feel that if there is a successful resolution to these cases, individual suits, not class actions will be the best way to get maximum payouts to our clients. If you’ve been injured by an Ethicon Surgical Stapler, we know you’ve suffered emotionally and economically, and want to work with you personally to obtain the maximum compensation for the damages caused by your injuries. Contact us today to learn more about your legal rights.
Do I Have an Ethicon Stapler Recall Lawsuit?
The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Ethicon stapler recall lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if you or a loved one was injured, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.