—#161502

Product

Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

FDA product code: GDW — Staple, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K132493
Affected lot / code info: Product number: EGIARADXT Lot code: N6L0351X

Why it was recalled

The device cartridge disengaged during use due to manufacturing error.

Root cause (FDA determination)

Process control

Action the firm took

Medtronic sent an "URGENT MEDICAL RECALL LETTER" dated September 13, 2017, was issued to customers titled "Covidien Endo GIA Black Radial Reload with Tri-Staple Technology" urging customers to quarantine and return unused product to recalling firm. Questions or concerns can be directed to: feedback.customerservice@Covidien.com. For further questions, please call (203) 492-5000.

Recalling firm

Firm: Covidien LLC
Address: 60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

Distribution pattern: Internationally, including Japan. No USA Customers

Timeline

Recall initiated: 2017-09-15
Terminated: 2018-12-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161502. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.