On Oct. 31, Ethicon issued a Class I recall of its Echelon Flex Endopath staplers because the device fails to completely form staples during surgery.
The recall was issued because the device may contain an out of specification component within the jaw of the device. This is what can lead to malformed staples that don’t completely form during use.
In the event that this happens, it could lead to a prolonged surgery, postoperative connection (anastomotic) leak, hemorrhage, hemorrhagic shock, additional surgery and/or intervention, or death.
The sterile, single patient staplers are used to both cut and staple internal tissue. They can be used in a variety of surgeries and procedures such as gynecologic, urologic, thoracic, pediatric, and general surgeries– both open or minimally-invasive.
As of October 3, 2019 there have been seven serious injuries and one death reported in association with the Ethicon surgical stapler.
Ethicon is a subsidiary of pharmaceutical and surgical device giant, Johnson & Johnson. The following Echelon Flex devices are part of this recal:
ECHELON FLEX™ ENDOPATH® Staplers:
- 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)
- Product Codes: EC60A, PCEE60A, PLEE60A, PSEE60A
- Lot Numbers: See specific lot numbers in the table below
- Manufacturing Dates: July 18, 2019 – August 3, 2019
- Distribution Dates: August 1, 2019 – September 26, 2019
- Devices Recalled in the U.S.: 8,256
- Date Initiated by Firm: October 3, 2019
Health care professionals who may have this surgical stapler on hand must pay attention to the following guidelines, as outlined by the Food and Drug Administration and Ethicon:
- Examine their inventory immediately to determine if they have product subject to this recall on hand and quarantine such product(s).
- Remove the product subject to this voluntary recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in their facility who needs to be informed.
- If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating.
- Have completed the Business Reply Form (BRF) confirming receipt within 3 business days of receipt of the firm’s letter, even if they do not have product subject to this recall.
- Keep the letter visibly posted for awareness until all product subject to this recall has been returned to Stericycle. While processing their returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records.
- If customers have the affected product, they are required to return unused impacted ECHELON FLEX ENDOPATH 60mm Staplers subject to this recall that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall by December 31, 2019. Any non-affected product and any product returned after the date specified will not be replaced.
- To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling Stericycle at 1-866-918-8756.
Do you have an Ethicon Echelon Flex recall lawsuit?
If you or someone you love was injured by an Ethicon Echelon Flex surgical stapler involved in this recall, you should contact the lawyers at Johnson // Becker. You may be entitled to financial compensation by filing an Ethicon stapler lawsuit. We offer a Free Case Evaluation and would be honored to speak to you.