Recall Z-1228-2023— Covidien, LP
Class II · Ongoing
Class II FDA medical device recall by Covidien, LP, initiated 2023-01-25. It names one FDA 510(k) clearance: K160176. Product: Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT. Reason: Affected lots have the potential for a broken sled vane, which 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 be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death..
- Recalling firm
- Covidien, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-01-25
- Firm location
- North Haven, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Reason for recall
Affected lots have the potential for a broken sled vane, which 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 be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.
Data sourced from openFDA. This site is unofficial and independent of the FDA.