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Tri-staple™ 2.0 black intelligent reload
Official notice
8 Feb 2023
Last checked
8 Feb 2023
An official Health Canada notice concerns 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 Published 2023-02-08.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72664
Official notice
2023-02-08
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand
Manufacturer
Phone
Brand: Covidien, Tri-staple™ 2.0 Black Intelligent Reload.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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