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Recall Observatory FDA recall evidence

Device product

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

Z-0834-2024

December 11, 2023

Class II

Product summary

Firm
Ethicon Endo-Surgery Inc
Event
Event 93735
Status
Ongoing
Classification
Class II
Quantity
22,616 (US), 4,476 (OUS)
Official record key
device-enforcement:Z-0834-2024

Official wording

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.

Code information: UDI-DI 10705036014928 Lots 442C02 and 442C03

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada and Brazil.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.