Parker Waichman LLP

Thoratec Updates Warning for HeartMate II Controller, Says Risk is Greater for Certain Patients

Thoratec is updating the warning for its recalled HeartMate II left ventricular assist device, which has been linked to eight deaths or serious injuries. According to Mass Device, the company updated its warning to say that patients who first had an older controller and then switched to the pocket controller were exposed to greater risks. […]

Thoratec is updating the warning for its recalled HeartMate II left ventricular assist device, which has been linked to eight deaths or serious injuries. According to Mass Device, the company updated its warning to say that patients who first had an older controller and then switched to the pocket controller were exposed to greater risks. The company said that the issue is attributed to “ailure to completely connect the driveline during the process of exchanging pocket system controllers,” carries a greater risk for patients who originally had an older controller model and then tried to upgrade to the newer pocket controller.

“Patients who received the pocket controller as a replacement for an older model (EPC system controller) may be at a higher risk of experiencing difficulty in the controller exchange process, as there are differences between the 2 controller models, especially differences related to the connection of the driveline,” said Thoratec.

In a press release, Thoratec said the rate of serious injury or death associated with the device was 1.5 percent, (8 out of 523) for patients that switch from an older controller to the pocket model. For patients switching from 1 pocket controller to another, the rate is 0.1 percent.

The recall was initially issued earlier this month. At the time, 4 deaths and 5 incidences of loss of consciousness or other signs of hypoperfusion were reported. Thoratec said that eight of the nine cases had been initially trained to use its older EPC system but were using the pocket controller.

Thoratec received premarket approval for the pocket controller last May. Over 2,000 patients have been prescribed the device since that time. The company said that people were “at a higher risk of experiencing difficulty in the controller exchange process,” if they were first given an older HeartMate II controller and then switched over to the pocket version.

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
Parker Waichman has been so much help with my case over the past few years. It has finally come to an end with a positive outcome. I would also like to thank Benita Rollis, who personally kept me up to date every step along the way. She was able to answer every question I had and always replied in a very timely and professional matter. I cant thank your firm enough. All I can say is thank you from me and my entire family.
Ed McKenna
2 years ago
5 Star Reviews 150
Great law office super nice staff. Thank you Jorge you helped me a lot
Cecilia Ortiz
4 years ago
5 Star Reviews 150
Don't know where to begin, as I speak of ur honest n responsible worker Mrs. M.Josama if I had a law firm I would ask u to please except her resignation . She would have to work for my firm. One of a kind.
Ruth Rodriguez
4 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