Johnson & Johnson Recalls Echelon Flex Endopath Staplers Due to Patient Injuries
In October 2019, Johnson & Johnson recalled several models of defective surgical staplers produced by the company’s Ethicon unit. After multiple reports that Ethicon’s Echelon Flex Endopath surgical staplers led to leakage, bleeding, and other dangerous complications after surgery, the U.S. Food & Drug Administration (FDA) classified this move as a Class I recall, which is the most serious recall category – and it is only declared for the risk of significant injury and death.
The affected Ethicon surgical stapler models include the following:
- ECHELON Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter
- ECHELON Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter
- ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 44cm Shaft Length
- ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 34cm Shaft Length
If you or a loved one have suffered from complications after an internal surgical procedure involving Ethicon staplers, it’s possible that you may have grounds for a lawsuit against Johnson & Johnson. Our defective medical device attorneys at Ashcraft & Gerel are available to help you file a lawsuit from Washington DC, Virginia, Maryland, or anywhere else in the country.
Defects in Surgical Staplers Prompt Recalls
In the case of the Echelon Flex Endopath Stapler devices, the FDA reports that these products cause misformed staples and do not always properly close surgical incisions. Because these models cut and staple at the same time, there are certain unique safety concerns associated with these products.
However, Ethicon is far from the only manufacturer facing scrutiny for stapler defects: In March 2019, the FDA released an open letter to health care providers warning that the agency had received over 41,000 medical device reports about adverse events involving surgical staplers. In total, there were at least 9,000 serious injuries and 366 deaths associated with these events.
Many of these injuries and deaths were linked to problems such as:
- Misfired staples
- Malformed staples
- Difficulties when firing
- Stapler failure
- User error during application
When Am I Eligible to File a Claim?
When you develop life-threatening infections and injuries after a surgical procedure, it isn’t always easy to identify the root cause. In some cases, your surgical team may be at fault; in other cases, your losses could be linked back to a recalled or faulty surgical stapler. Whatever the reason for your injuries, we recommend that you check with your healthcare provider to see if your surgeon used an Ethicon surgical stapler or a stapling device during your procedure.
In addition to the Echelon Flex Endopath staplers, Ethicon also recently recalled the following staplers for insufficient firing and failure to completely form staples:
- Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and
- Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples
Our attorneys at Ashcraft & Gerel are committed to helping you seek compensation after a surgical stapler injury. With over $1 billion recovered for injured clients across the country, our highly-skilled and tenacious lawyers can apply 65 years of experience to your case. Well known for our litigation against Big Pharma and major medical device manufacturers, we never back down from a challenge.