GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto

FDA device recall Z-2672-2026 · posted 2026-07-02 · Open, Classified

Recall details

Recalling firm

W L Gore & Associates, Inc.

Reason for recall

Due to catheter separation

Action taken

On 05/21/2026, the firm thru a third-party (Sedgwick) sent via certified mail an "URGENT Medical Device Safety Correction/Field Safety Notice" informing customer that Gore received 5 reports involving catheter separation of the GORE TAG Thoracic Branch Endoprosthesis (TBE) Side Branch (SB) Component during clinical use. In all cases, the failure occurred at the interface between the main catheter shaft and an over molded transition near where the trailing end of the device is positioned on the catheter. Customers are being reminded of pertinent Instructions for Use and Warnings and Considerations. -Per the IFU - Gore recommends use of a through-and-through side branch wire where clinically and anatomically feasible. -rotation of the SB delivery catheter is cautioned against: Caution: Do not rotate the SB Component delivery catheter. Catheter breakage or inadvertent deployment has occurred. -Caution: Do not continue advancement or retraction of the & delivery catheter if resistance is felt. Stop and assess the cause of resistance. Vessel, endoprosthesis, or delivery catheter damage may occur. -Complete and sign the "RETURN ACKOWLEDGEMENT FORM" and return to FieldActionTeam@wlgore.com and share notice with those within their institution For Questions - contact me, Gore Customer Service (email: MPDCustomerCare@wlgore.com or by phone at 800-528-8763), or your local Field Sales Associate.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MIH

Quantity affected

467 devices

Distribution

Worldwide - U.S. Nationwide distribution including in the states and territories of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NY,

Date initiated

2026-05-19

Date posted

2026-07-02

Location

Flagstaff, AZ