Ethicon Endo-Surgery Inc medical device recall: Endopath Echelon Vascular White Reload for Advanced Placement Tip

Reason for recall

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.

What the classification means

• Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Apr 22, 2025. FDA classified it 28 days later, on May 20, 2025. Distribution reported by FDA: US distribution nationwide. OUS distribution to EMEA, LATAM, APAC, and Canada. Ethicon Endo-Surgery Inc has 27 recalls in our records.

Recalled products (1)

• Z-1746-2025 Class I Ongoing

  Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35

  Codes / lots: UDI-DI GTIN 10705036014591 Packaging Batches: 917C65 895C93 918C15 938C92 936C69 929C38 948C78 990C81 979C81 400D82 962C74 506D29 379D80 413D56 418D41 419D47 415D43 427D07 434D35 442D78 442D83 444D96 456D87 455D03 493D27 468D88 482D30 502D90 489D62 134D80 112D03 155D33 159D49 181D11 194D77 125D04 167D13 223D59 175D72 234D11 238D70 261D10 270D69 317D74 194D76 349D54 347D73 317D73 356D54 326D66 319D76 338D99 336D39 356D53 367D26 378D04 214D17

  Quantity: 678,526