U.S. Food and Drug Administration08.17.17
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product:
The Zenith Alpha Thoracic Endovascular Graft is intended to treat isolated lesions (not including dissections) in a patient's main blood vessel that carries blood from the heart down through the chest (descending thoracic aorta) into the abdomen. The device is used in patients who have a suitable vascular anatomy for endovascular repair.
Cook Medical Inc. is recalling the Zenith Alpha Thoracic Endovascular Graft when used for the treatment of BTAI because blood clots (thrombus) may form inside the device after implantation. Cook Medical is also aware of reported cases where the graft became blocked or closed (occlusion) when used to treat BTAI. Thrombosis or occlusion may lead to serious adverse health consequences, including death.
On March 22, 2017, Cook Medical Inc. sent an "Urgent: Medical Device Correction and Removal" notification to all affected customers. This recall notification included a description of the problem and reason for the recall, list of affected products and customer actions to be taken in response to the recall notification.
On June 22, 2017, Cook Medical Inc. sent an updated “Urgent: Medical Device Correction and Removal” notification to all affected customers. This recall notification informed customers the Instructions for Use (IFU) for this device were updated to remove the indication for use in BTAI. As a result, it is necessary to remove specific sizes of this device (grafts with a proximal or distal diameter of 18-22mm) that would likely be used only for the treatment of BTAI.
Cook Medical Inc. recommends that patients already treated with the Zenith Thoracic Endovascular Graft for the BTAI indication should be followed according the current IFU and with considerations outlined in Cook Medical’s March 22, 2017 "Medical Device Correction and Removal" notification.
A Cook Medical Sales Representative will follow-up with all affected customers and provide a corrected IFU.
Recalled Product:
- Zenith Alpha Thoracic Endovascular Graft
- Lot or serial numbers: All lots
- Manufacturing dates: April 10, 2015 to January 3, 2017
- Distribution dates: October 29, 2015 to March 10, 2017
- Devices recalled in the U.S.: Approximately 4,500 devices will be relabeled and 500 devices (18 to 22 mm) will be removed.
The Zenith Alpha Thoracic Endovascular Graft is intended to treat isolated lesions (not including dissections) in a patient's main blood vessel that carries blood from the heart down through the chest (descending thoracic aorta) into the abdomen. The device is used in patients who have a suitable vascular anatomy for endovascular repair.
Cook Medical Inc. is recalling the Zenith Alpha Thoracic Endovascular Graft when used for the treatment of BTAI because blood clots (thrombus) may form inside the device after implantation. Cook Medical is also aware of reported cases where the graft became blocked or closed (occlusion) when used to treat BTAI. Thrombosis or occlusion may lead to serious adverse health consequences, including death.
On March 22, 2017, Cook Medical Inc. sent an "Urgent: Medical Device Correction and Removal" notification to all affected customers. This recall notification included a description of the problem and reason for the recall, list of affected products and customer actions to be taken in response to the recall notification.
On June 22, 2017, Cook Medical Inc. sent an updated “Urgent: Medical Device Correction and Removal” notification to all affected customers. This recall notification informed customers the Instructions for Use (IFU) for this device were updated to remove the indication for use in BTAI. As a result, it is necessary to remove specific sizes of this device (grafts with a proximal or distal diameter of 18-22mm) that would likely be used only for the treatment of BTAI.
Cook Medical Inc. recommends that patients already treated with the Zenith Thoracic Endovascular Graft for the BTAI indication should be followed according the current IFU and with considerations outlined in Cook Medical’s March 22, 2017 "Medical Device Correction and Removal" notification.
A Cook Medical Sales Representative will follow-up with all affected customers and provide a corrected IFU.