Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, Item Code EGIA45AV
FDA Recall Z-2509-2018 · Posted 2018-07-19
Recalling FirmCOVIDIEN MEDTRONIC
Recall StatusOpen, Classified
Product CodeGDW
Date Initiated2018-05-22
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.
Firm Action
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: [email protected] or fax to (800) 895-6140.
*Product purchased through distributor: [email protected] or fax it to (203) 492-7719.
Root Cause
Process control
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.