Health product recall

Tri-Staple™ 2.0 Black Intelligent Reload

Brand(s)
Last updated

Summary

Product
Tri-Staple™ 2.0 Black Intelligent Reload
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Tri-Staple™ 2.0 Black Intelligent Reload N2D0195Y SIG60AXT

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies

Covidien Llc

15 Hampshire Street, Mansfield, Massachusetts, United States, 02048

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-72664