Dive Brief:

• Philips stopped selling an implant used to repair damaged arteries after reports of 20 injuries and some devices needing to be removed.
• The Food and Drug Administration said in a Monday recall notice that all customers should stop using Philips’ Tack Endovascular System immediately. The agency classified the recall as Class I, the highest risk category.
• Philips is not aware of serious harm or death accompanying the use of the device, a company spokesperson wrote in an email. The FDA said no deaths were reported.

Dive Insight:

Philips acquired the Tack Endovascular System as part of its $275 million purchase of Intact Vascular in 2020. The metal device is intended to treat arterial dissections, or tears in the artery, after a minimally invasive procedure to open a blocked artery. 

At the time, the device was marketed as the first FDA-approved vascular implant for below-the-knee treatment. Now, Philips is pulling the device from the market because of “challenges experienced by customers during use, including events where additional interventions were required to retrieve or remove the Tack implant,” according to the FDA notice.

Using the devices can lead to partial or completely blocked flow, holes or tears in the inner lining of the artery, and perforation of the artery, according to the FDA. The agency also flagged long-term risks including re-narrowing a widened or stented vessel, bypass surgery, amputation and death. 

Philips told customers in a Jan. 10 letter to immediately check for and quarantine any affected devices. Philips said it will start a return and credit process after customers complete a response form. 

More than 2,900 affected devices were distributed in the U.S. and Europe, according to an FDA enforcement report. Philips said all but 246 units were distributed in the U.S.