Philips has issued a recall for its Tack Endovascular System, citing difficulties encountered during use that required additional interventions to reposition or remove the implant. The recall, classified as the most serious type by the U.S. Food and Drug Administration (FDA), involves removing the devices from clinical settings and discontinuing their distribution.

The affected products include:

Tack Endovascular System (4F, 1.5-4.5mm), 150cm (UDI: 00863328000196)

Tack Endovascular System (6F, 3.5-6.0mm), 135cm (UDI: 00863328000127)
Tack Endovascular System (6F, 4.0-8.0mm), 135cm (UDI: 00850003494036)

Batch codes associated with the recall range from 331281 to 349049.

Risks and reported injuries
The recall follows reports of complications where the Tack implant required retrieval or removal, posing risks of occlusion, arterial dissection, perforation, pain, tissue loss, restenosis, bypass surgery, amputation, and death. So far, 20 injuries have been reported, but no deaths.

The Tack Endovascular System is used to repair dissections in blood vessels after angioplasty, securing damaged tissue to the vessel lining.

Actions for health care providers
Philips sent an Urgent Medical Device Recall letter to customers on January 10, 2025, advising immediate cessation of use. Affected facilities should:

Check inventory and quarantine affected products
Stop using and distributing the Tack Endovascular System
Return a completed response form within seven days, even if no affected devices are on hand
Share the recall notice with all relevant staff and locations
Philips will facilitate returns and issue credits based on completed forms.

Reporting issues
Health care professionals and consumers can report adverse events through the FDA’s MedWatch program. For further assistance, U.S. customers are advised to contact their local Philips representative.

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