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Health product recall

Zenith Alpha Thoracic Endovascular Grafts (2017-06-23)

Starting date:
June 23, 2017
Posting date:
June 30, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-63788

Affected Products

  1. Zenith Alpha Thoracic Endovascular Graft - Proximal Component
  2. Zenith Alpha Thoracic Endovascular Graft - Proximal Tapered Component
  3. Zenith Alpha Thoracic Endovascular Graft - Distal Component

Reason

William Cook Europe ApS has learned of an issue affecting the Zenith Alpha Thoracic Endovascular Grafts.  As described in the recent field safety notice 2017FA0001 of March 2017 regarding the Zenith Alpha Thoracic Endovascular Graft, there were complaints involving thrombosis/occlusion of the product when used to treat blunt thoracic aortic injury (BTAI). Since that time, Cook Medical has received additional complaints for the same problem. Although the complaints were from patients treated prior to issuance of the above noted field safety notice, cook medical is initiating a voluntary correction of the instructions for use (IFU) and is also voluntarily removing specific sizes of the Zenith Alpha Thoracic Endovascular Graft from the market. The manufacturer is voluntarily removing the indication for blunt thoracic aortic injury. The specific sizes of 18-22 mm used for the BTAI indication is being recalled from the market and will no longer be available.  The IFU will be corrected for the remaining sizes on the market used for endovascular treatment of patients with isolated lesions of the descending thoracic aorta.

Affected products

  1. Zenith Alpha Thoracic Endovascular Graft - Proximal

Lot or serial number

All lots

Model or catalog number
  • ZTA-P-18-105
  • ZTA-P-18-127
  • ZTA-P-20-105
  • ZTA-P-20-127
  • ZTA-P-22-105
  • ZTA-P-24-105
  • ZTA-P-26-105
  • ZTA-P-26-149
  • ZTA-P-28-109
  • ZTA-P-28-155
  • ZTA-P-28-201
  • ZTA-P-30-109
  • ZTA-P-30-132
  • ZTA-P-30-155
  • ZTA-P-30-201
  • ZTA-P-32-109
  • ZTA-P-32-155
  • ZTA-P-32-201
  • ZTA-P-34-113
  • ZTA-P-34-161
  • ZTA-P-34-209
  • ZTA-P-36-113
  • ZTA-P-36-161
  • ZTA-P-36-209
  • ZTA-P-38-117
  • ZTA-P-38-142
  • ZTA-P-38-167
  • ZTA-P-38-217
  • ZTA-P-40-117
  • ZTA-P-40-167
  • ZTA-P-40-217
  • ZTA-P-42-121
  • ZTA-P-42-173
  • ZTA-P-42-225
  • ZTA-P-44-125
  • ZTA-P-44-179
  • ZTA-P-44-233
  • ZTA-P-46-125
  • ZTA-P-46-152
  • ZTA-P-46-179
  • ZTA-P-46-233
Companies
Manufacturer

William Cook Europe APS

Sandet 6

Bjaeverskov

4632

DENMARK



B. Zenith Alpha Thoracic Endovascular Graft - Proximal Tapered Component

Lot or serial number

All lots

Model or catalog number

ZTA-PT-30-26-108

ZTA-PT-32-28-178

ZTA-PT-32-28-201

ZTA-PT-34-30-161

ZTA-PT-34-30-209

ZTA-PT-36-32-161

ZTA-PT-36-32-209

ZTA-PT-38-34-167

ZTA-PT-38-34-217

ZTA-PT-40-36-167

ZTA-PT-40-36-217

ZTA-PT-42-38-173

ZTA-PT-42-38-225

ZTA-PT-44-40-179

ZTA-PT-44-40-233

ZTA-PT-46-42-179

ZTA-PT-46-42-233

Companies
Manufacturer

William Cook Europe APS

Sandet 6

Bjaeverskov

4632

DENMARK



C. Zenith Alpha Thoracic Endovascular Graft - Distal Component

Lot or serial number

All lots

Model or catalog number

ZTA-D-30-160

ZTA-D-32-160

ZTA-D-34-190

ZTA-D-36-190

ZTA-D-38-197

ZTA-D-40-147

ZTA-D-40-197

ZTA-D-42-204

ZTA-D-44-211

ZTA-D-46-211

ZTA-DE-26-104

ZTA-DE-30-108

ZTA-DE-34-112

ZTA-DE-38-91

ZTA-DE-42-94

Companies
Manufacturer

William Cook Europe APS

Sandet 6

Bjaeverskov

4632

DENMARK


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