Health product recall

GORE EXCLUDER System (2019-12-18)

Starting date:
December 18, 2019
Posting date:
January 24, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72169

Last updated: 2020-01-24

Affected Products

  1. GORE EXCLUDER AAA Endoprosthesis
  2. GORE EXCLUDER Iliac Branch Endoprosthesis - Iliac Branch Component
  3. GORE EXCLUDER Iliac Branch Endoprosthesis - Internal Iliac Component

Reason

Gore has identified 346 reportable events worldwide between 1/1/2013 and 8/5/2019 for leading end catheter component separation. Gore has issued a Physician Safety Information Letter with IFU Summary of Changes to ensure awareness of these events.

Affected products

  1. GORE EXCLUDER AAA Endoprosthesis

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

More than 10 numbers, contact manufacturer.

Companies
Manufacturer

W.L. GORE & ASSOCIATES INC

1505 NORTH 4TH STREET

FLAGSTAFF

86004

Arizona

UNITED STATES

B. GORE EXCLUDER Iliac Branch Endoprosthesis - Iliac Branch Component

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

CEB231010
CEB231210
CEB231410

Companies
Manufacturer

W.L. GORE & ASSOCIATES INC

1505 NORTH 4TH STREET

FLAGSTAFF

86004

Arizona

UNITED STATES

C. GORE EXCLUDER Iliac Branch Endoprosthesis - Internal Iliac Component

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

HGB161007
HGB161207
HGB161407

Companies
Manufacturer

W.L. GORE & ASSOCIATES INC

1505 NORTH 4TH STREET

FLAGSTAFF

86004

Arizona

UNITED STATES