Philips pulls endovascular devices from market after safety issues prompt Class I recall
The U.S. Food and Drug Administration (FDA) has announced that Philips is recalling its Tack Endovascular System due to significant patient safety concerns, including 20 reports of injuries.
This device is being completely pulled from the market. Philips will not sell it anymore, and interventional cardiologists are urged to stop using it immediately.
The Tack Endovascular System is designed to help treat peripheral arterial dissections following balloon angioplasty procedures either above or below the knee. This recall has been put in place after customers repeatedly encountered issues when using the device, sometimes requiring an additional procedure to retrieve the implant.
The Tack Endovascular System in use. Graphic courtesy of Philips.
“Philips will no longer distribute this system for use,” according to the FDA advisory. “The use of affected product may cause serious adverse health consequences, including short-term risks of partial or completely blocked blood flow (occlusion), holes or tears in the inner lining of the artery (dissection) through the entire artery wall (perforation), as well as long-term risks such as pain, tissue loss, re-narrowing of a widened or stented vessel (restenosis), the need for bypass surgery, amputation and death.”
This recall includes all three sizes of the Tack Endovascular System. Customers are urged to quarantine all affected devices to ensure they will not be used going forward. Philips has said it will start issuing returns and crediting customers once the required response form has been filled out and returned.
Click here to read the full advisory.
Philips statement provides additional context
“Philips has become aware of challenges customers may have experienced with affected systems, and reports of instances where additional clinical intervention was required during device use,” a company spokesperson told Cardiovascular Business. “These issues may affect approximately 3,000 units, with all but 246 units in the U.S. The Tack Endovascular System is no longer being distributed by Philips.”
Philips also emphasized that it is unaware of any serious injuries or patient deaths associated with the use of this system.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.