Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system , Item Code EGIA30CTAV

FDA device recall Z-2516-2018 · posted 2018-07-19 · Open, Classified

Recall details

Recalling firm

COVIDIEN MEDTRONIC

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.

Action taken

On May 22, 2018, all U.S. consignees received an UPDATED URGENT MEDICAL DEVICE RECALL and RETURN FORM notice via Federal Express or certified. The initial notice was sent to impacted customers on April 26, 2018. Customers are advised to take the following required actions: 1. Immediately discontinue use, and quarantine affected products listed 2. Return affected product as indicated. 3. Complete the Recalled Product Return Form even if you do not have inventory and submit by either method below: * Product purchased directly from Medtronic: feedback.customerservice@Covidien.com or fax to (800) 895-6140. *Product purchased through distributor: FCAMITG@Covidien.com or fax it to (203) 492-7719.

Root cause

Process control

Status

Open, Classified

Product code

GDW

Distribution

Nationwide U.S.A. Internationally to: Albania, Algeria, Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Iceland, Ireland,

Date initiated

2018-05-22

Date posted

2018-07-19

Location

NORTH HAVEN, CT