Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia Recalled by COVIDIEN MEDTRONIC Due to Device may be missing a sled component. The...

Date: May 22, 2018
Company: COVIDIEN MEDTRONIC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact COVIDIEN MEDTRONIC directly.

Affected Products

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

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About COVIDIEN MEDTRONIC

COVIDIEN MEDTRONIC has 55 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report