ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST)…

Date

Feb. 7, 2024

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Ethicon Endo-Surgery Inc

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

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.

Distribution pattern

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

Quantity

22,616 (US), 4,476 (OUS)

Codes and lots

UDI-DI 10705036014928 Lots 442C02 and 442C03

Recall started

Dec. 11, 2023

Device type

Staple, Implantable

Root cause (FDA)

Under Investigation by firm

What the company told customers

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, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET.

Recall number

Z-0834-2024

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0834-2024. The agency record governs; check it and the company before acting.