Philips recalls Tack Endovascular System after reports of multiple injuries

NETHERLANDS – Philips has pulled its Tack Endovascular System from the market following reports of 20 injuries linked to its use.

The device, designed to repair arterial dissections after a procedure to open blocked arteries, has led to complications requiring additional medical interventions.

The U.S. Food and Drug Administration (FDA) has issued a Class I recall, the most serious type, urging all users to immediately stop using the device. The FDA reported no deaths, but warned of serious health risks, including:

• Blocked blood flow (occlusion)
• Holes or tears in artery walls (dissection or perforation)
• Pain, tissue loss, or restenosis (re-narrowing of arteries)
• Severe complications such as bypass surgery, amputation, or death

Philips confirmed the recall in a statement: “We are not aware of any deaths associated with the device but are taking this action to ensure patient safety.”

Background and market withdrawal

Philips acquired the Tack Endovascular System in 2020 as part of its $275 million purchase of Intact Vascular.

The device was the first FDA-approved vascular implant for below-the-knee treatments. It works by securing damaged artery tissue after angioplasty, helping to prevent further damage.

Despite its initial success, Philips decided to pull the device from the market due to “challenges experienced by customers during use, including events where additional interventions were required to retrieve or remove the Tack implant.”

Next steps for customers

Philips instructed customers in a Jan. 10 letter to check for any affected devices and quarantine them immediately. The company will begin a return and credit process after customers complete a response form.

According to the FDA, more than 2,900 units were distributed in the U.S. and Europe, with 246 still unaccounted for in the U.S.