Philips is pulling from the market an implant designed to help repair the interior of damaged blood vessels following a serious product recall.
The company’s Tack endovascular system includes a small, metal, stentlike implant to help support tears and dissections in the walls of the peripheral arteries following balloon angioplasty procedures performed both above and below the knee.
The move comes after several cases were reported where additional interventions were required to retrieve or remove the minimally invasive Tack implant, as well as 20 patient injuries. According to an FDA notice, all customers should stop using the system immediately, and Philips is coordinating returns and credits for the device.
Philips first alerted healthcare providers of potential issues in mid-January, including with the deployment and stability of the Tack once it has been deployed within the vessel. Specific problems could include migration of the implant and failures to help mend the dissections, as well as causing potential blockages in blood flow to the limbs.
The FDA subsequently categorized the recall as Class I, its most serious, with about 3,000 systems distributed across the U.S. and Europe.
Philips acquired the Tack system through its $360 million deal for Intact Vascular in 2020 before folding it into its image-guided therapy business.