A Soft-Vu Omni Flush Angiographic Catheter recall has been issued due to reports of separation of the tip of the catheter from the main body. Tip separation can potentially lead to internal organ injury and possibly cause kidney failure, intestinal failure, stroke and death. Affected patients and their families may be eligible to file a lawsuit and recover compensation with the help of a defective medical device attorney.
For more information, contact Attorney Group today. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated Soft-Vu Omni Flush Angiographic Catheter recall lawyer who can assist you throughout the legal process.
What is a Soft-Vu Omni Flush Angiographic Catheter?
Soft-Vu Omni Flush Angiographic Catheters are used to inject contrast dye into blood vessels in preparation for a cardiac angiogram, a special type of x-ray used to discover blocked or narrowed coronary arteries.
Soft-Vu Omni Flush Angiographic Catheter Recall
Stryker Sustainability Solutions initiated a recall of its Angiodynamics Soft-Vu Omni Flush Angiographic Catheters on June 1, 2016, due to reports of separation of the tip of the device from the main body. According to a U.S. Food and Drug Administration (FDA) recall notice, tip separation can lead to loss of device function, potential surgical intervention to retrieve a separated segment, or other complications, including blocking blood flow to bodily organs. Separation of the tip could also lead to internal organ injury as well as stroke, kidney failure and intestinal failure. Other serious adverse health consequences may also occur, including death.
A complete list of model/item and lot numbers associated with the devices can be found here. Devices were manufactured from November 7, 2003 to October 18, 2008 and distributed from January 5, 2004 to December 3, 2008. Over 160 recalled devices were either distributed or used in Texas, Utah, Pennsylvania, California, Vermont, Maine, Washington, Virginia, New York, Maryland, and Connecticut.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Who is Affected by the Soft-Vu Omni Flush Angiographic Catheter Recall?
According to the FDA’s notice, hospitals and health care professionals using the Soft-Vu Omni Flush Angiographic Catheter and patients undergoing cardiovascular angiographic procedures involving the devices may be affected. Stryker Sustainability Solutions sent a letter notifying customers of the high possibility of tip separation on June 1, 2016.
Patients and health care professionals are asked to discontinue use of the affected lots, check their inventories for affected lots of the unused products, ship all affected devices back to Stryker, and acknowledge receipt of recall letter by contacting Stryker Sustainability Solutions. Patients and health care professionals are also encouraged to report any adverse reactions or quality problems to the company.
How a Soft-Vu Omni Flush Angiographic Catheter Recall Lawyer Can Help
Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by defective catheters may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those killed may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.
For more information, contact Attorney Group. After you contact us, an attorney will follow up to answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.
Please note that the law limits the time you have to pursue a claim or file a lawsuit for an injury. If you think you have a case, you should not delay taking action.