Philips Removes and Discontinues Distribution of Tack Endovascular System Due to User Challenges

The recent recall of the Tack Endovascular System by Philips has raised concerns about the safety of medical devices used in critical procedures. The recall involves the removal of certain devices from the market, as they have been associated with complications that require additional interventions to reposition or remove the implant. The U.S. Food and Drug Administration (FDA) has classified this recall as a Class I recall, the most serious type, because continued use of the affected devices could lead to serious injury or even death.

The Affected Philips Tack Endovascular System

The Philips Tack Endovascular System is a device used to treat dissection (tearing) of blood vessels following balloon angioplasty or stent placement. The system works by attaching a small implant to the damaged tissue inside the blood vessel to help repair the dissection. However, challenges encountered during its use have led to its recall. The recall specifically affects various sizes of the Tack Endovascular System, including 4F and 6F sizes, with unique device identifiers (UDI) and batch codes listed as follows:

• 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

The batch codes impacted by the recall are 332905 – 349049, 332824 – 336121, and 331281 – 336152. These affected devices are being removed from distribution due to issues related to their functionality, including complications that may necessitate additional procedures to reposition or remove the Tack implant.

Immediate Actions for Affected Customers

As of January 10, 2025, Philips Image Guided Therapy Services has issued an Urgent Medical Device Recall letter to all affected customers. The company recommends the following actions:

1. Stop using the Tack Endovascular system immediately. 
2. Check inventory for affected devices and quarantine them to prevent further use.
3. Do not open or use any identified products.
4. Complete, sign, and return the response form within seven days of receipt of the recall letter. This form is required even if no affected product is present.
5. Share the recall notice with all device users and any other locations where affected products might have been transferred.

These steps are critical to ensure that the affected devices are removed from circulation and returned to Philips to mitigate any potential health risks to patients.

Reason for the Recall: Potential Health Risks

Philips is recalling the Tack Endovascular Systems due to reported user challenges during device implantation. These challenges include complications that necessitated additional medical interventions to retrieve or remove the Tack implant. The recall has been issued because the use of these devices may lead to serious health consequences. These risks include both short-term and long-term complications, such as:

• Occlusion (partial or complete blockage) of blood flow in the artery
• Dissection (tearing) of the artery wall, which can lead to further injury or death
• Perforation (a hole or tear through the entire artery wall), a severe complication that can lead to life-threatening situations
• Pain, tissue loss, and re-narrowing of a widened or stented vessel (restenosis)
• The need for bypass surgery, amputation, or even death

While there have been 20 reported injuries related to the use of the affected devices, it is important to note that no fatalities have been reported as of the latest update. Despite this, the potential for serious harm remains high, and all affected devices are being removed from the market.

Device Use and How It Works

The Tack Endovascular System was designed for use in endovascular procedures, where it helps repair damage to blood vessels caused by balloon angioplasty or stenting. After a blood vessel is widened using a balloon or stent, the Tack implant is used to secure the artery’s inner lining and facilitate the healing of any resulting dissection. The device was intended to be a critical tool in treating certain types of vascular damage, but due to user challenges and adverse events, it has now been discontinued.

How to Report a Problem

Healthcare professionals and consumers who have experienced issues with the Tack Endovascular System are encouraged to report these problems to MedWatch, the FDA’s Adverse Event Reporting Program. This allows the FDA to track issues with medical devices and take appropriate action to protect public health. The UDI (Unique Device Identifier) system helps improve the reporting and tracking process, ensuring that problematic devices can be identified and corrected faster.

For customers in the U.S. who have questions about the recall or need assistance, Philips advises contacting their local representative. It is essential that healthcare providers stay informed about recalls like this one to prevent adverse outcomes in patients.

Legal Assistance for Victims of Dangerous Medical Devices

If you or someone you know has been affected by the Philips Tack Endovascular System or any other recalled or defective medical device, KBD Attorneys can help. Medical device recalls can be complex, but our team of experienced attorneys specializes in helping victims of dangerous and defective products. We have a proven track record of success in representing clients who have suffered injuries due to faulty medical devices, and we understand the intricacies of product liability cases.

Our legal team can guide you through the process of seeking compensation for medical expenses, pain and suffering, lost wages, and other damages that may arise from the use of defective medical products. We will work tirelessly to hold the responsible parties accountable and ensure that you receive the justice you deserve.

KBD Attorneys has extensive experience with medical device recalls and a deep understanding of the regulations that govern the safety and distribution of these products. We know the challenges that come with pursuing claims against large corporations and are prepared to take on the big players in the industry to protect your rights. Our dedicated approach to litigation and our commitment to our clients have earned us a reputation as trusted advocates for those affected by defective products.

If you have been harmed by the Philips Tack Endovascular System or another recalled product, contact KBD Attorneys today for a consultation. We are here to help you navigate the legal process and secure the compensation you deserve.