Parker Waichman LLP

HeartWare Malfunctions may have Caused Deaths, FDA Says

HeartWare International is responsible for software and design malfunctions that may have led to serious injuries and death, the U.S. Food and Drug Administration (FDA) said in a letter. According to Worcester Business Journal Online, the agency cited 27 complaints of controller failure for HeartWare’s ventricular assist device received by the company. The failure was […]

HeartWare Malfunctions may have Caused Deaths, FDA SaysHeartWare International is responsible for software and design malfunctions that may have led to serious injuries and death, the U.S. Food and Drug Administration (FDA) said in a letter. According to Worcester Business Journal Online, the agency cited 27 complaints of controller failure for HeartWare’s ventricular assist device received by the company. The failure was most likely caused by electrostatic discharge. Two deaths and four serious injuries were included in the complaints.

According to Worcester Business Journal Online, the violations were spurred by an inspection of the company’s production facility in Miami Lakes, Fla. in January. HeartWare began taking actions to remediate the situation, but did not indicate if these actions were effective, the FDA said.

The FDA also accuses the company of failing to implement procedures to address 238 complaints of premature battery failure. HeartWare also did not resolve complaints regarding loose driveline connectors.

The FDA letter also alleged that HeartWare failed to keep proper records of investigations, maintin procedures for validating device design and failed to validate computer software its intended purpose.

The company was given 15 days to correct the violations and explain how to prevent similar situations from occurring in the future.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Nicole Marcano-Frias
5 years ago
5 Star Reviews 150
Tina Morace provided me excellent support throughout the application process. She provided me with valuable follow-up on questions and any actions needed on my part. You have a valued employee with Tina
Joe Sinopoli
2 months ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value Parker Waichman is an excellent law firm. Thank you Christina Morace my Paralegal, assigned to the case for guiding me through the process of filing the necessary paperwork for the 9/11 victims compensation fund. Your knowledge and ability to communicate it to me made the entire process much easier..
allan doyno
3 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038