Philips Recalls Tack Endovascular Systems and Stops Distribution

Philips is recalling the Tack endovascular system because of what it says are user challenges that have led to additional interventions needed to retrieve or remove the implant. The US Food and Drug Administration deemed the move a Class I recall, the most serious type.

The manufacturer will no longer distribute the Tack system, and the recall notice recommends that customers stop using it immediately.

The Tack system is indicated for use in peripheral arterial dissections that occur following balloon angioplasty. The Tack implant is used to repair the dissection by attaching the damaged tissue to the inner lining of the blood vessel.

While no deaths have been reported, the recall notes that there have been 20 injuries and that the product also poses long-term risks including pain, tissue loss, and restenosis, among others.