A Class I Recall has been issued for the HeartMate II LVAS Pocket System Controller due to a serious risk for patient injury or death. A Class I Recall is considered the most serious recall and is issued when there is a reasonable probability that use of the medical device or product will cause serious adverse health consequences or death.
The manufacturer, Abbott-Thoratec, has received at least 70 reports in which the controller malfunctioned after an exchange. Exchanges may be necessary in the event of a device alarm or malfunction during ventricular assist therapy. Unfortunately, 26 deaths and 19 injuries have been reported. These deaths occurred when patients attempted to exchange controllers while at home or otherwise away from the hospital.
According to the FDA, the Pocket System Controller is a power supply that connects to the implanted HeartMate II LVAS pump through a lead, or drive line, under the skin. The device powers the LVAS device that assists in circulating blood when the heart is too unable to properly do so.
Affected model/item numbers are: 105109, 106015, 106762, 107801 and were manufactured between July 2012 and December 2016.
New patients with the recalled devices were notified that they would receive upgraded hardware and software, whereas existing patients will receive updated device software and alarm guides for both their primary and backup controllers. If a replacement is necessary, Abbott-Thoratec will replace the device at no cost. Additionally, health care providers were encouraged to report any adverse side effects or other events related to the use of the HartMate II LVASPocket System Controller. The manufacturer is expected to work to coordinate office visits, conduct software updates, and update product labeling.
The product injury attorneys at The Ruth Law Team have been fighting on behalf of injured persons for more than 35 years. If you or your loved one has been injured due to a defective medical device such as the HeartMate II LVAS Pocket System Controller, contact us today. We can be reached day or night at (888) 783-8378, or simply fill out the Free Case Evaluation form on this page.