Recall Z-0908-2018 ยท GDW Staple, Implantable
Covidien LLC
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
| Date | Sep 15, 2017 |
| Status | Terminated |
| Reason | The device cartridge disengaged during use due to manufacturing error. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 163 |
| Distribution | Internationally, including Japan. No USA Customers |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132493 | ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY Covidien, LLC, Oct 23, 2013 |