Recall Z-1746-2025 ยท GDW Staple, Implantable
Ethicon Endo-Surgery Inc
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
| Date | May 20, 2025 (initiated Apr 22, 2025) |
| Status | Open, Classified |
| Reason | Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death. |
| Root cause | Device Design |
| Action | On April 22, 2025, the firm began to notify affected customers through letters titled, "URGENT: MEDICAL DEVICE CORRECTION." Customers were instructed to notify all users of the affected device and to post a copy of the communication, which reminds users of the Instrument Lockout Instructions that are part of the product IFU. ***UPDATED 8/20/2025*** In May 2025, all customers received an updated letter which stated that Ethicon would also provide in-person training to all impacted US consignees regarding managing a lockout condition. |
| Quantity | 678,526 |
| Distribution | US distribution nationwide. OUS distribution to EMEA, LATAM, APAC, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141952 | ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED Ethicon Endo-Surgery, Inc., Nov 24, 2014 |