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Health Canada Medical devices

Tri-Staple™ 2.0 Black Intelligent Reload

Issued February 8, 2023
Issue
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
Hazard description
Performance
Product
Product name
Tri-Staple™ 2.0 Black Intelligent Reload
Reference
ID
RA-72664