Recall Z-0834-2024 ยท GDW Staple, Implantable
Ethicon Endo-Surgery Inc
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
| Date | Jan 26, 2024 (initiated Dec 11, 2023) |
| Status | Open, Classified |
| Reason | There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay. |
| Root cause | Under Investigation by firm |
| Action | On December 11, 2023, the firm notified affected consignees through URGENT VOLUNTARY MEDICAL DEVICE RECALL (REMOVAL) letters. Customers were instructed to cease use and distribution of affected product lots. Customers should examine their inventory immediately to determine if they have affected product. Affected product should be quarantined. Unused affected product should be returned. If you require any assistance with returning product, please contact Sedgwick at 888-591-5087 and reference Event # 6925. If you have additional questions regarding this voluntary medical device recall, plea |
| Quantity | 22,616 (US), 4,476 (OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada and Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163454 | ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads Ethicon Endo-Surgery, LLC, Jan 5, 2017 |