On October 30, 2019, the FDA announced a Class I recall, the most serious type of recall for medical devices that may cause serious injuries or death, regarding Johnson and Johnson’s Ethicon subsidiary’s recall of its ECHELON FLEX™ ENDOPATH® staplers for failure to completely form staples.
The Echelon Flex Endopath staplers are sterile, single patient use devices that cut and staple internal tissue. The staplers can be used in open or in minimally-invasive surgical procedures, including gynecologic, urologic, thoracic, pediatric, and general surgeries.
Ethicon is recalling these devices because some devices may contain an out of specification component within the jaw of the device, which could lead to malformed staples. If a problem with the staple line is not recognized or is not adequately addressed, there is a potential risk of prolonged surgery, postoperative connection (anastomotic) leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death. As of October 3, 2019, 7 serious injuries and 1 death had been reported to Ethicon for affected product codes.
On October 3, 2019, Ethicon sent a letter to customers who purchased the affected staplers and provided instructions. Health care facilities, distributors, and other customers must:
– 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.
– In addition, the FDA’s letter to health care providers on surgical staplers and staples from March 2019 includes general recommendations for surgeons.
If you or a loved one suffered harm due to a defective medical device, you should promptly consult with a medical device claim lawyer in your U.S. state who may investigate your defective medical device claim for you and represent you in a claim against a medical device manufacturer, if appropriate.
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