PVAD Lawsuit | 2025 Latest Updates

PVAD Lawsuit Overview

The Paracorporeal Ventricular Assist System (PVAD) lawsuits stem from a recall involving defective black collet and nut components that can disconnect from the cannula during use, potentially causing life-threatening complications. The primary allegations against manufacturer Thoratec involve failure to properly design and test the device, as well as inadequate warning about risks. PVAD units were distributed worldwide from January 1, 2004, to October 2, 2006, with Thoratec issuing an urgent Class I recall on March 30, 2007, later classified by the FDA, though exact unit and customer counts remain unspecified in available records.

Latest PVAD Lawsuit Updates

As of August 9, 2024 – According to Schmidt & Clark, LLP, lawsuits are being considered against manufacturers of certain PVAD devices due to serious complications such as clotting, device failure, and patient fatalities.

March 30, 2007 – Thoratec issued an Urgent Medical Device Correction notice to PVAD customers regarding a defect involving mismatched black collet and nut components. The FDA later classified this as a Class I recall, indicating a high-priority risk, prompting Thoratec to coordinate warning label applications and instructions for hospitals and medical facilities using these devices.

FDA Reports and Statistics

According to available records, PVAD units were distributed worldwide from January 1, 2004, to October 2, 2006, with an estimated 2,484 units sent to 146 customers (123 in the U.S., 23 outside the U.S.) per legal sources, though FDA data does not specify exact counts. Units with serial numbers 10745 or less shipped after January 2004 may be affected, per reported claims.

On March 30, 2007, Thoratec issued an Urgent Medical Device Correction notice to PVAD customers alerting them to the hazard, with the FDA later classifying it as a Class I recall. The recall was initiated because the device may contain a black collet and nut intended for an older, larger-diameter cannula, posing a serious disconnection risk when used with newer, smaller-diameter cannulas [1].

PVAD Injuries & Side Effects

The PVAD defect can lead to serious and potentially fatal health complications when the device malfunctions during use.

• Device Disconnection: The black collet and nut may disconnect from the cannula during use, leading to blood flow disruption
• Blood Flow Interruption: Sudden cessation of circulatory support to the heart
• Organ Damage: Reduced blood flow can cause damage to vital organs, particularly the brain, liver, and kidneys
• Heart Failure: Patients may experience worsening heart failure symptoms if the device malfunctions
• Death: In severe cases, device failure can lead to fatal outcomes

Do You Qualify for a PVAD Lawsuit?

You may qualify for a PVAD lawsuit if:

• You or a loved one received a PVAD between January 2004 and February 2007
• Your device has a serial number of 10745 or less
• You experienced device malfunction, disconnection, or related health complications
• The complications required medical treatment or hospitalization
• You can provide medical documentation linking your injuries to the PVAD device

Evidence Required for a PVAD Lawsuit

To support your claim, you’ll need:

• Medical records documenting your PVAD implantation and serial number
• Documentation of complications or adverse effects experienced
• Medical bills related to treatment of complications
• If possible, preservation of the actual device that malfunctioned
• Expert testimony linking the device defect to your health issues

Damages You Can Recover

Compensation from a PVAD lawsuit may include:

• Medical expenses for additional treatments and surgeries
• Lost wages due to inability to work
• Pain and suffering caused by the device failure
• Punitive damages against the manufacturer
• In wrongful death cases, funeral costs and loss of support

PVAD Recall Information

The PVAD recall was initiated on March 30, 2007, when Thoratec issued an Urgent Medical Device Correction notice. The recall affected:

• PVADs with serial numbers 10745 or less shipped after January 2004, per reported claims, though FDA specifies units manufactured from January 1, 2004, to October 2, 2006
• Devices containing a black collet and nut intended for older, larger-diameter cannulas
  Thoratec, under the recall classified as Class I by the FDA, took the following actions:
• Applied warning labels to affected devices
• Instructed against using the black collet and nut with smaller-diameter cannulas, with no specific directive to dispose of expired original design cannulas
• Provided guidance to ensure safe configurations for current PVAD users
• Distributed the Urgent Medical Device Correction notice to hospitals and physicians monitoring PVAD patients

Statute of Limitations for PVAD Lawsuits

The statute of limitations for filing a PVAD lawsuit varies by state but typically ranges from 1-3 years from the date of injury or from when you reasonably discovered the connection between your injury and the defective device. Some states may have special provisions for medical device claims, so it’s crucial to consult with an attorney promptly to ensure your claim is filed within the legal timeframe.

Related Articles:

• Thoratec Recall Lawsuit
• Bard Eclipse IVC Filter Lawsuit
• Option ELITE IVC Filter Lawsuit

FAQs

1. What is the Paracorporeal Ventricular Assist System?

The PVAD is part of the Vascular Assist Device system, a mechanical pump that helps a weakened heart pump blood through the body. It serves as a “bridge to transplant” for patients awaiting heart transplants and helps those recovering from heart surgery who require continued circulatory support.

2. What specifically caused the PVAD recall?

The recall was issued because some PVAD devices contained a black collet (circular rim) and nut designed for older, larger-diameter cannulas. When used with newer, smaller-diameter cannulas, this mismatch created a risk of disconnection during use, potentially causing life-threatening complications.

3. How do I know if my PVAD device is affected by the recall?

PVADs with serial numbers 10745 or less that were shipped after January 2004 are potentially affected by this recall. Your medical records should indicate the serial number of your device, or your healthcare provider can help you determine if your device is included in the recall.

4. What compensation might be available through the PVAD lawsuit?

Compensation may include medical expenses, lost wages, pain and suffering, and other damages related to 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.

5. What evidence is needed to support a claim in the PVAD lawsuit?

Supporting evidence includes medical records documenting your use of the PVAD device, records of any complications or adverse effects experienced, expert testimony linking the device to your health issues, and documentation showing that the device was defective or that the manufacturer failed to provide adequate warnings.

6. 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.

7. What should I do with the PVAD device if it causes 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.

8. How long do I have to file a PVAD lawsuit?

The statute of limitations varies by state but typically ranges from 1-3 years from the date of injury or discovery of the connection between your injury and the device. Consult with an attorney promptly to ensure your claim is filed within the legal timeframe.

9. Is this a class action lawsuit or an individual claim?

PVAD cases may be handled as individual lawsuits or potentially grouped into multidistrict litigation (MDL) depending on the number of claims. Your attorney can advise on the best approach for your specific situation.

See all related medical device lawsuits our attorneys covered so far.

Take Action Now: Time-Sensitive Legal Claims

Time is limited to pursue legal action for PVAD-related injuries, with most states allowing only 1-3 years from the date of injury to file a claim. The clock may already be ticking on your right to compensation.

At Schmidt & Clark, LLP, we offer:

• Free, confidential consultations to evaluate your case
• No upfront costs or fees to begin your lawsuit
• Payment only if we win your case through settlement or verdict

Don’t delay – contact our experienced medical device litigation team today to protect your rights and pursue the compensation you deserve.

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.

Reference:

[1] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53461