If you or a loved one have been affected by the Paracorporeal Ventricular Assist System recall and/or experienced PVAD malfunctions, failure, or injury, you should contact us immediately. You may be entitled to compensation and we can help.
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What is the Paracorporeal Ventricular Assist System?
The PVAD is a part of the Vascular Assist Device. A ventricular assist device is a mechanical pump that helps a person’s heart that is too weak to pump blood through the body.
The VAD is designed to provide sufficient blood flow to the damaged or diseased heart. It is sometimes referred to as a “bridge to transplant” since it can help a patient survive until a heart transplant can be performed.
The device is also used for patients who are recovering from heart surgery and must continue on a heart-lung machine.
From January 2, 2004, through February 23, 2007, 2484 units were distributed to 146 customers (distributors, hospitals, and medical centers), 123 customers within the U.S., and 23 customers outside the U.S. PVADs with serial numbers 10745 or less were shipped after January 2004.
What is the problem?
The PVAD may contain a black collet (circular rim) that holds a rod-like piece in place (nut). This black collet and nut was intended to be used with a cannula (a small tube) of an older design that had a larger diameter.
If this black collet and nut is used with the current design of a cannula that has a smaller diameter, it can disconnect during use.
The blood is pumped from the VAD through the cannula into the patient. (The black collet is similar to how a washer works with a nut). It is called a black collet because the collet and matching nut are painted black for easy identification.
FDA Action
On March 30, 2007, Thoratec issued an Urgent Medical Device Correction notice to all VAD customers alerting them to the hazard. The letter instructed them that a Thoratec representative would contact them to make arrangements to apply a warning label to the affected devices.
The letter also informs them to dispose of any expired original design caged tip atrial cannula and to:
- Do not use the black collet and nut with any current design VAD;
- Make sure that all current patients using PVADs are using the appropriate collet nut, and
- Provide a copy of the product safety bulletin to all outlying hospitals and/or physicians who may be following patients implanted with PVADs and provide contact information with the acknowledgment form.
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Do I have a PVAD Recall Lawsuit?
The Medical Device and Product Liability Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in medical device recall lawsuits.
We are currently investigating the possibility of handling individual Paracorporeal Ventricular Assist System (PVAD) litigation nationwide and currently accepting new Thoratec PVAD recall claims.
If you or a loved one have been affected by the Paracorporeal Ventricular Assist System recall and/or experienced PVAD malfunctions, failure, or injury, you should contact us immediately. You may be entitled to compensation and we can help.