Recall Z-2515-2018— COVIDIEN MEDTRONIC

Name: FDA recall Z-2515-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-22

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: Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 45 mm Vascular/Medium, Item Code SIG45ACTAVM. 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

Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 45 mm Vascular/Medium, Item Code SIG45ACTAVM

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.