FDA Issues Most Serious Recall for Philips Tack Endovascular System
A major medical device recall has been issued for the Philips Tack Endovascular System due to serious risks of complications that have led to additional medical interventions and life-threatening health issues. The U.S. Food and Drug Administration (FDA) has classified this as the most severe type of recall, warning that continued use of the device could cause serious injury or death.
The recall affects multiple versions of the Tack Endovascular System, a device designed to repair damaged blood vessels following angioplasty. Reports indicate that the device has caused complications requiring emergency interventions, including blood vessel blockages, tears in artery walls, and the need for additional surgeries, bypass procedures, or amputations. The manufacturer has completely halted distribution of the device and advised all healthcare providers to immediately stop using affected units.
With 20 reported injuries linked to this product, the recall raises urgent concerns about patient safety and the long-term risks associated with implantable medical devices. Individuals who have received the Tack Endovascular System implant should be aware of the potential health risks and seek medical guidance if they experience complications.
Severe Health Risks Linked to the Tack Endovascular System
Patients who have undergone vascular procedures using the Tack Endovascular System are now at risk for serious medical conditions. The device was intended to attach damaged tissue to artery walls, but design flaws have led to dangerous complications that require additional medical interventions.
Some of the short-term dangers associated with this recalled device include:
- Partial or total artery blockages (occlusion), restricting blood flow to vital organs
- Tears in artery walls (dissection or perforation), leading to severe internal bleeding
- Intense pain and inflammation requiring emergency care
The long-term consequences can be even more devastating, including:
- Tissue loss and chronic pain caused by restricted blood circulation
- Blood vessel narrowing (restenosis), requiring repeat procedures
- Bypass surgery or amputation for cases where blood flow cannot be restored
- Potentially fatal complications due to untreated vascular damage
Although no deaths have been reported so far, the severity of the documented injuries raises concerns about the safety of implantable endovascular devices and the lack of adequate testing before they reach the market.
Legal Options for Patients Harmed by the Recalled Device
Patients who have suffered medical complications due to the Tack Endovascular System may be entitled to compensation for their injuries. When a medical device is found to be defective or unsafe, the manufacturer can be held legally responsible for the harm it causes.
Victims of dangerous medical implants may be able to file a lawsuit against the device manufacturer, distributors, or healthcare providers if they have experienced:
- Emergency surgeries to remove or reposition the Tack implant
- Severe complications such as artery damage, pain, or restricted blood flow
- Long-term health consequences requiring ongoing medical treatment
- Permanent disability, including amputations or loss of mobility
Filing a product liability claim allows victims to seek financial compensation for their suffering. These claims can recover damages for medical expenses, lost wages, pain and suffering, and long-term disability costs.
Why Legal Representation is Critical in Medical Device Lawsuits
Pursuing a lawsuit against a medical device manufacturer requires strong legal knowledge and experience in handling product liability claims. Companies that produce and distribute defective medical devices have legal teams working to deny responsibility and minimize payouts, making it difficult for injured patients to obtain justice on their own.
A qualified attorney can assist victims by:
- Gathering medical records and expert testimony to prove the device caused their injuries
- Filing legal claims against manufacturers and other responsible parties
- Negotiating settlements to ensure victims receive fair compensation
- Taking cases to trial if necessary to hold negligent companies accountable
Without legal representation, many patients struggle to receive compensation, leaving them burdened with medical bills and ongoing health complications. Hiring an experienced attorney ensures that victims have an advocate fighting for their rights and the compensation they deserve.
Compensation Available for Victims of Defective Medical Devices
Patients harmed by the Tack Endovascular System recall may be entitled to significant compensation for:
- Medical bills for emergency procedures, surgeries, and long-term care
- Lost wages and loss of earning capacity if unable to return to work
- Pain and suffering for physical and emotional distress caused by complications
- Disability compensation for permanent injuries
- Wrongful death damages for families who lost a loved one due to the device’s failure
Manufacturers have a responsibility to ensure the safety of their medical devices before placing them on the market. If they fail to protect patients, they must be held accountable for the harm they cause.
.svg){kind=small}
.avif)
.avif)
