Class 2 Device Recall EEA Circular Stapler with TriStaple Technology

• Date Initiated by Firm: August 17, 2018
• Create Date: October 04, 2018
• Recall Status: Terminated on April 10, 2020
• Recall Number: Z-0070-2019
• Recall Event ID: 81043
• 510(K)Number: K172361
• Product Classification: Stapler, surgical - Product Code GAG
• Product: 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.
• Code Information: P8A0976X P8A0977X P8A0978X P8A0979X P8A0980X P8A0981X P8B1538X P8B1539X P8B1540X P8B1541X P8B1542X P8C0032X P8C0033X P8C1177X P8C1178X P8C1179X P8C1180X P8C1181X P8C1183X P8D1405X P8D1406X P8D1407X P8D1408X P8D1409X P8D1410X P8D1411X P8E1211X P8E1212X P8E1213X P8E1214X P8E1215X P8E1216X P8E1217X P8E1304X P8E1305X
• Recalling Firm/ Manufacturer: COVIDIEN LLC; 15 Hampshire St; Mansfield MA 02048-1113
• For Additional Information Contact: Ms. Angela Pietrosimone; 203-492-8153
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process design
• Action: 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.
• Quantity in Commerce: 1,902
• Distribution: Worldwide Distribution - US Nationwide in the states of CA, FL, IL, NC, NY, UT. and the countries of Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Reunion, Spain, Sweden, Switzerland, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GAG and Original Applicant = Covidien