The US Food and Drug Administration (FDA) has classed the recall of the Philips’ Tack Endovascular Systems as Class I, the most serious type.
Philips has advised customers to cease using the system immediately. Furthermore, the company plans to stop the distribution of the Tack system. The US FDA notice lists 20 reported injuries from the use of the system.
The Tack endovascular system is used to treat a tear (dissection) of the blood vessels after they are widened using a balloon or stent (angioplasty). The Tack implant attaches damaged tissue to the inner lining of the blood vessel to repair dissection.
According to the FDA notice, “Philips is recalling Tack Endovascular Systems due to challenges experienced by customers during use, including events where additional interventions were required to retrieve or remove the Tack implant.”
The notice lists that the use of the affected products may cause adverse health consequences. These include short-term risks of partial or completely blocked blood flow (occlusion), holes or tears in the inner lining of the artery (dissection) through the entire artery wall (perforation), as well as long term risks such as pain, tissue loss, re-narrowing of a widened or stented vessel (restenosis), the need for bypass surgery, amputation, and death.
Philips first advised the customers to stop the use of Tack devices though an urgent medical device recall letter dated 10 January 2025. The letter advises customers to check inventory and quarantine affected devices to prevent use. Adding that they should not open or use any identified products, and to complete, return, and sign the response form to start the return and credit process.
Ongoing recall problem at Philips
Philips has had device recall issues in the past few years. Latest of which was back in January, when the company recalled heart monitor application software used to process and analyze patient data. The US FDA classed the recall as Class I, with reports of 109 injuries and two deaths.
The company is also dealing with the massive respiratory device recall. The recall started in mid-2021 and involved millions of CPAP and BiPAP ventilators and other respiratory devices. Following multiple recalls, and a ProPublica report that noted that between 2010 and 2021, the company withheld warnings about black particles, dirt, dust and other contaminants in devices’ airway chambers from the FDA.
In its 2024 annual report, Philips noted that it has reached a personal injury settlement in relation to the Respironics recall. The aggregate amount of $1.1 billion is expected to pay out in the first half of 2025.
