Tri-Staple™ 2.0 Black Intelligent Reload

Specific lots have the potential for a broken sled vane component. A broken sled vane may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may potentially be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.

Medtronic has received one complaint related to this issue causing serious injury, which included a delay in treatment and tissue trauma. No deaths have been reported.

Recall start date: January 25, 2023