Published by 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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FAQs
What compensation might be available through the PVAD lawsuit?
Compensation may include medical expenses, lost wages, pain and suffering, and other damages related to the complications caused by the PVAD device. In severe cases, compensation might also cover long-term health effects, disability, or wrongful death if the device failure led to fatal outcomes.
What evidence is needed to support a claim in the PVAD lawsuit?
Supporting evidence may include medical records documenting your use of the PVAD device, records of any complications or adverse effects you experienced, expert testimony linking the device to your health issues, and possibly documentation showing that the device was defective or that the manufacturer failed to provide adequate warnings.
Can I sue the manufacturer if a PVAD device caused the death of a loved one?
Yes, if a PVAD device caused the death of a loved one, you may be able to file a wrongful death lawsuit against the manufacturer. Compensation may cover medical expenses, funeral costs, loss of income, and emotional suffering related to the loss.
What should I do with the PVAD device if it caused complications?
If possible, preserve the PVAD device and any related components as evidence, especially if you believe it malfunctioned or was defective. This evidence may be crucial in supporting your claim. Your lawyer can advise you on the best way to handle the device and whether it should be inspected by experts.
See all related medical device lawsuits our attorneys covered so far.
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.
To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: