Philips Halts Distribution of Tack Endovascular System Over Class I Recall

Philips is recalling the Tack endovascular system due to challenges experienced by customers during use. The Tack system is used to treat blood vessel dissection after they’re widened using a balloon or stent. The implant attaches damaged tissue to the blood vessel’s inner lining to repair dissection.

The Tack endovascular system is made by Intact Vascular, and distributed by Philips.

The recall was initiated following reports of user challenges from customers, including events where further interventions were needed to retrieve or remove the Tack implant. Using the product has the short-term risks of partial or complete occlusion, arterial dissection or perforation. Long-term risks include pain, tissue loss, restenosis, need for bypass surgery, amputation, and death.

This Class I recall—the most serious type—involves removing devices from where they’re used or sold. Philips urged that all customers should stop using the Tack system immediately and the company will no longer distribute it for use.

There have thus far been 20 reported injuries, with no reports of death due to the issue.

Philips’ January 10 Urgent Medical Device Recall letter advised customers to quarantine affected devices and not to open or use identified products. The response form attached to the letter should be completed, returned and signed within a week. The return and credit process will begin based on the completed form.