Philips Recalls Tack Endovascular System: Serious Safety Concerns

Philips is recalling the Tack Endovascular System due to serious safety concerns that could lead to injury or death. The recall affects multiple versions of the device, including different sizes and batch codes. The recall has been identified as the most serious type by the FDA.

Affected products include:

• Tack Endovascular System (4F, 1.5-4.5mm), 150cm
• Tack Endovascular System (6F, 3.5-6.0mm), 135cm
• Tack Endovascular System (6F, 4.0-8.0mm), 135cm

UDI/Catalog Numbers and Batch Codes:

• UDI/Catalog Numbers: 00863328000196/154150041, 00863328000127/156135061, 00850003494036/206135061
• Batch Codes: 332905 – 349049, 332824 – 336121, 331281 – 336152

The FDA recommends:

• Immediately stop using the affected products.
• Check inventory for affected devices and quarantine them.
• Do not use or open the affected products.
• Complete and return the response form within 7 days, even if no product is on hand.
• Acknowledge receipt of the recall by emailing the response form to Philips.

The recall is due to complications faced by customers, including difficulty retrieving or removing the Tack implant. Serious health risks associated with continued use include blocked blood flow, artery tears, and long-term issues like pain, tissue loss, re-narrowing of the vessel, and the need for bypass surgery or amputation.

There have been 20 reported injuries, but no fatalities.

The Tack Endovascular System is used to treat blood vessel dissection after balloon angioplasty or stenting. It attaches damaged tissue to the artery’s inner lining for repair.