Cook Medical responded to confusion over its recent recall involving the Zenith Alpha Thoracic Endovascular Graft.
A recent Cook Medical recall stirred up quite a bit of confusion after FDA classified it as a Class I recall late last week.
|Cook recalled certain sizes of its Zenith Alpha Thoracic Endovascular Graft from the market because those sizes are primarily used for treating a blunt thoracic aortic injury.|
The device in question is the Zenith Alpha Thoracic Endovascular Graft, which FDA approved in September 2015.
The device is used to treat thoracic aneurysms and blunt thoracic aortic injury (BTAI), but the company has decided to remove the BTAI indication from the device's instructions for use (IFU) due to the potential for blood clots to form inside the device after it has been implanted. Cook also pulled certain sizes of the device (18 mm to 22 mm) because those specific sizes are primarily used to treat BTAI.
"There's been a lot of confusion on this particular recall because we recalled only select sizes of the Zenith Alpha Thoracic device. In addition, we made a correction to all remaining device IFU's to remove the indication for BTAI," Marsha Lovejoy, a Cook spokeswoman, told Qmed.
Cook issued a press release Thursday in an effort to better explain the recall.
The company said it has received an increase in reports of blood clots and blockage forming inside the Zenith Alpha Thoracic Endovascular Graft specifically in the treatment of BTAI.
Lovejoy said the company still has 12 diameters of the Zenith Alpha graft available that are indicated for thoracic aneurysms.
Cook said it made the IFU correction in June and sent letters to notify customers and distributors. The letter asked that the recalled sizes of the device be returned to Cook for credit.
The company said customers with concerns about the recall or the IFU correction should contact its customer relations department at 1-800-457-4500 or 1-812-339-2235.
Amanda Pedersen is Qmed's news editor. Contact her at [email protected]