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
- GORE EXCLUDER AAA Endoprosthesis
- GORE EXCLUDER Iliac Branch Endoprosthesis - Iliac Branch Component
- 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
-
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