EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.

The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.

All U.S. consignees were notified via Federal Express or certified mail on August 17, 2018. The letter informs customers of the potential for use of a device to have an incorrect tissue gap. Required Actions: 1. Please quarantine and discontinue use of the affected item code and lots listed above. 2. Please return affected product. All unused products from the affected item codes and lots must be returned. If you purchased directly from Medtronic, return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. If you purchased from a distributor, complete all fields on the form and contact your distributor directly to arrange for return of product. 3. If you have distributed EEA" staplers with Tri-Staple" technology listed above, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.