Recall Z-2503-2018— COVIDIEN MEDTRONIC
Class II · Ongoing
Class II FDA medical device recall by COVIDIEN MEDTRONIC, initiated 2018-05-22. It names one FDA 510(k) clearance: K111825. Product: Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT. Reason: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents..
- Recalling firm
- COVIDIEN MEDTRONIC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-05-22
- 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
Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT
Reason for recall
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Data sourced from openFDA. This site is unofficial and independent of the FDA.