The U.S. Food & Drug Administration (FDA) has announced yet another Class I recall for surgical staplers marketed by Ethicon, Inc.
This latest action involves more than 8,200 Echelon Flex Endopath staplers that may contain an out-of-specification component within the jaw of the device that could result in 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,” the FDA recall notice states.
Class I is the agency’s most serious recall category, and is reserved for devices that may cause serious injury or death. Before Ethicon moved to pull the products from the market, recalled Echelon Flex Endopath staplers had already been implicated in at least one fatality and seven serious injuries.
Echelon Flex Endopath staplers are single-patient products indicated to cut and staple internal tissue during open or laparoscopic procedures, including gynecologic, urologic, thoracic, pediatric, and general surgeries.
More than 8,200 devices are affected by this latest surgical stapler recall, including:
The recalled surgical staplers were manufactured from July 18, 2019 until August 1, 2019, and distributed from August 1, 2019 until September 26, 2019.
Ethicon is asking customers to check their inventories, quarantine any recalled staplers in their possession, and return the products before the end of the year to receive a replacement.
Ethicon also recalled more than 92,000 Endo-Surgery Curved Intraluminal Staplers earlier this year, following reports that those devices had misfired or failed to completely form staples during procedures. The FDA designated that action a Class I recall in May, confirming that the staplers had seriously injured at least two patients.
Just two months earlier, the FDA disclosed that internal surgical staplers had been associated with 41,000 medical device reports since January 2011, including 366 patient deaths, 9,000 serious injuries, and 32,000 malfunctions.
The FDA has long classified internal surgical staples as low risk (class I) medical devices. However, the agency has since proposed reclassifying internal surgical staplers as moderate risk (class II) devices, which would subject such instruments to additional regulatory scrutiny.