Home / Recalls / COVIDIEN MEDTRONIC / Z-2505-2018

Z-2505-2018 Class II Ongoing

Recalled by COVIDIEN MEDTRONIC — NORTH HAVEN, CT

FDA device recall Z-2505-2018 was initiated by COVIDIEN MEDTRONIC on May 22, 2018 and is designated Class II. 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 leakag… The recall status is ongoing.

Recall Details

Product Type: Devices
Report Date: July 25, 2018
Initiation Date: May 22, 2018
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity

Product Description

Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA60AXT

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.

Distribution Pattern

Nationwide U.S.A. Internationally to: Albania, Algeria, Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Iceland, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malta, Martinique, Moldova, Morocco, Namibia, Netherlands, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates & United Kingdom

Code Information

N7L0974KX, N7M0486KX, N7M0762KX & N8A0363KX

Other recalls by COVIDIEN MEDTRONIC

Z-2511-2018 Class II — Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technol (May 22, 2018)
Z-2512-2018 Class II — Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple Tec (May 22, 2018)
Z-2514-2018 Class II — Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system (May 22, 2018)
Z-2507-2018 Class II — Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 m (May 22, 2018)
Z-2510-2018 Class II — Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, (May 22, 2018)
Z-2509-2018 Class II — Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, Item (May 22, 2018)
Z-2504-2018 Class II — Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, Item (May 22, 2018)
Z-2513-2018 Class II — Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Med (May 22, 2018)
Z-2508-2018 Class II — Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Vas (May 22, 2018)
Z-2503-2018 Class II — Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item (May 22, 2018)