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Investigation Reveals Thousands of HVAD Heart Pumps Implanted Despite Multiple Reports of Defects

When your life is on the line, it is important to be able to trust your doctor and other medical professionals. After all, they have extensive specialized training, and the system is full of checks and balances, like the FDA’s approval for new drugs and medical devices.

Where can you turn when the system that ensures your safety fails?

At Colucci, Colucci & Marcus, PC, our Boston product liability attorneys have a long track record of holding negligent parties responsible. Faulty consumer products endanger thousands of lives every year. The award-winning personal injury lawyers of Colucci, Colucci & Marcus, PC, have been securing compensation for the damage defective products have caused for decades. Schedule your free consultation today by calling 617-917-3917.

Medtronic Stops Sale and Implants, Leaving HVAD Patients in Limbo

According to a recent investigation by ProPublica, “By the end of 2020, roughly 3,000 death reports and 20,000 injury report related to the HVAD [HeartWare Ventricular Assist Device, have] been filed with the FDA. Medtronic has stopped all sales.

In 2012, HeartWare was an independent company that won FDA approval to sell a device to keep heart patients alive while waiting for a transplant. However, patients were unaware that the machine had a history of defects dating back to 2011;

  • Manufacturing issues with HVAD: 2011
  • FDA issued 15 serious recalls of HVAD beginning in 2014
  • Included warning letter issued in June 2014 labeling device as “adulterated,” or that the HVAD did not meet the federal manufacturing standards
  • More inspections failed in 2015, 2016, 2017, and 2018
  • The 2018 report is the most recent and included violations cited in the 2014 inspection
  • As of June 2021, HVAD has 15 company-initiated “Class I” recalls
  • Recalls included problems that had been reported in inspections spanning 12 years. The HVAD fails to restart if disconnected from power and can leave patients without heart support
  • The FDA never penalized HeartWare or Medtronic, despite the numerous reports of defects.
  • Patients were unaware of the failed inspections
  • Patients were unaware of recalls

John Winkler, an HVAD patient, died of such a defect in 2014. Between 2013 and 2015, 18,000 HVAD’s were recalled, including John’s. He and his wife, Tina Winkler, were never notified of the recall. Tina Winkler filed suit after stumbling upon his serial number a year after his death on an online published recall list. She reached a confidential settlement with Medtronic.

Can a Boston Product Liability Attorney Help Patients with Faulty Medical Device Implants?

Massachusetts’s premier personal injury firm, Colucci, Colucci & Marcus, PC, has represented numerous victims of defective medical devices. Currently, they represent individuals in a suit against Stryker for injuries and complications caused by Stryker’s modular-neck and hip implant products.

If you or a loved one have been affected by a faulty medical device, consult with a Boston product liability attorney today. Our dedicated legal team has extensive experience handling complex medical manufacturing and design flaws.

Call Boston’s Premier Personal Injury Lawyers, Colucci, Colucci & Marcus, PC for the Answers You Need

When you need aggressive representation and a history of success, call Colucci, Colucci & Marcus, PC. Our Boston product liability lawyers have the skills, expertise, and resources you need to recover the damages you deserve. Schedule a free evaluation of your case today by clicking here or by calling 617-917-3917.

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