Recall Z-2510-2018— COVIDIEN MEDTRONIC
Class II · Ongoing
Class II FDA medical device recall by COVIDIEN MEDTRONIC, initiated 2018-05-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA45AXT. 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
Product description
Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA45AXT
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.