Ethicon ECHELON FLEX ENDOPATH Stapler Recall Lawyers
Recently, the Federal Drug Administration (FDA) announced a sweeping recall of the Ethicon ECHELON FLEX ENDOPATH, which is a surgical stapler often used to simultaneously cut and staple tissue during internal and even robotic surgical procedures.
The FDA classified this as a Class 1 Recall which is the most serious of product recalls – one they’ve proven is directly responsible for serious injuries and even death by individuals who received these surgical staples. The FDA issued the following letter to healthcare providers as the recall was officially announced.
What Kind Of Surgeries Are Typically Performed With This Surgical Stapler?
The recall affected a specific type of staple used by the ECHELON FLEX ENDOPATH Stapler and was used by surgeons between the dates of March 15th, 2018 and November 1st, 2019. Most commonly, these surgical staples are used for the following types of surgeries or procedures:
- Bariatric Procedures
- Colorectal cancer Procedures
- Endo-related Procedures
- Gastrointestinal Procedures
- Gynecologic & urologic Procedures
- Thoracic Procedures
If you or a loved one underwent one of these types of surgery between March 15th, 2018 and November 1st, 2019 your surgeon may have used a recalled surgical stapler. Don’t hesitate to call our team at 1-800-590-4116 to learn how we can help you get justice and the compensation you deserve for your injuries.
Why Were These Surgical Staplers Recalled?
The Ethicon Surgical Staple recall affected a specific size of a surgical staple (60A) that had been manufactured to sub-par qualities causing this staple to misfire during it’s stapling procedure. Per the official recall, the following staple types, and product codes were affected by the October 2019 recall:
- 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)
This recall affected more than 5.700 units which had been manufactured between July 18, 2019 – August 3, 2019, and then distributed between August 1, 2019 – September 26, 2019, to physicians and surgeons.
The misfiring staples in these Flex 60 products caused severe misalignments of the surgical staples upon firing from the device which could cause severe injuries and even deaths to the patients. These misalignments can impair healing, cause unnecessary bleeding, and damage completely healthy tissue.
What Kind of Complications or Symptoms Would Arise From Receiving Recalled Surgical Staples?
As this type of surgical staple is typically reserved for internal and endo-related procedures, the injuries sustained may not be immediately visible, but that does not mean they may not be severe and even life-threatening.
Some of these injuries or symptoms can include:
- Anastomotic leaks (internal leakage) near or around the surgical site
- Bleeding (internal)
- Colostomy bags
- Follow Up Procedures
- Life-long digestive issues
- Post-surgery nutritional deficiencies
Would My Surgeon or Doctor Have Told Me If I Received Ethicon Surgical Staples?
Not every surgeon may have been aware that the surgical staple procedure was misfiring and causing malformed staples. As the procedures this instrument is used with is typically internal, the exterior of the body will often not be symptomatic of a malformed stapler, but following the patient’s surgery, there may be additional follow up procedures or health complications arising from a misfired surgical stapler.
Since this particular recall is so recent, you may not even notice complications until long after the surgery was performed. Speaking with our team and learning about your options can help you be prepared in the event you were facing such complications.
How Can McEldrew Young Purtell Help You?
If you suspect that you or a loved one is suffering from complications due to a recalled stapler surgery, or even suspect that the product was used in your procedure the best course of action is to consult with an expert law firm like McEldrew Young Purtell as soon as possible. With 30 years of experience in product liability cases, McEldrew Young Purtell is well suited to evaluate the situation and help determine if the injury suffered involved acts of medical negligence or professional malpractice. All birth injury claims are handled on a contingency basis.