| Developers: | Ethicon |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
Content |
History
2025: Identifying a Marriage That Kills People
On July 25, 2025, the U.S. Food and Drug Administration (FDA) announced the recall of defective Echelon Flex Powered Vascular Stapler Surgical Staplers, which are supplied by Ethicon Endo-Surgery (a division of Johnson & Johnson MedTech). The use of these tools can provoke the death of patients.
These products are intended for simultaneous cutting and stitching of fabrics. The braces are staggered on each side of the cut line. The identified problem is associated with unintentional blocking of devices during surgical procedures. Stapler can be activated for a short time, during which it does not cut or sew the tissue. In particular, the tool does not advance far enough for the incision, and the staples remain below the tissue contact surface. Additional medical action is required to safely release the device and remove it.
The FDA notice says the use of the defective Echelon Flex Powered Vascular Stapler tools can lead to serious adverse health effects for patients, including life-threatening bleeding, delayed surgery and death. As of the end of July 2025, one death and one case of harm to a person were recorded in connection with this problem.
As part of the recall program, Ethicon Endo-Surgery has released additional instructions on how to use the device and take the necessary actions if it is blocked. The issue affects products with a unique 10705036014591 ID. Medical facilities are provided with round-the-clock technical support.[1]
Notes
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