Parker Waichman LLP

Multiple Issues Prompt Class I Recall on HeartWare Device

Class I Recall on HeartWare Device. Our firm is investigating potential lawsuits on behalf of individuals implanted with the HeartWare Ventricular Assist Device (HVAD). In 2015, multiple recalls were issued for the system. Every recall was deemed a Class I, which is the U.S. Food and Drug Administration’s (FDA’s) most serious recall status. When recalls […]

HeartWare Device

Class I Recall on HeartWare Device. Our firm is investigating potential lawsuits on behalf of individuals implanted with the HeartWare Ventricular Assist Device (HVAD). In 2015, multiple recalls were issued for the system.

Every recall was deemed a Class I, which is the U.S. Food and Drug Administration’s (FDA’s) most serious recall status. When recalls are labeled as Class I, it means that there is a reasonable risk of serious injury or death when exposed to the recalled device.

If you or someone you know suffered complications related to the HeartWare Ventricular Assist System, contact Parker Waichman LLP today.

The HeartWare Ventricular Assist System is implanted in patients awaiting a heart transplant or who face life-threatening risks related to end-stage left ventricular heart failure. A pump is implanted in the area surrounding the heart to help it pump blood to the rest of the body.

The speed and function of the pump can be altered with a controller

The speed and function of the pump can be altered with a controller. According to a HeartWare press release issued June 8, 2015, five recalls were conducted for this system affecting product codes 1101 and 1103.

The company issued a voluntary Urgent Medical Device Correction on May 11, 2015 describing the following five major issues, according to the release:

  • Maintaining Continuous Power Supply: There are two power sources for the HVAD pump, and the system should never be disconnected from both at the same time. If neither power source is connected, a “double disconnect alarm” is present to alert patients. The battery powering this alarm can stop working over time. If a “double disconnect” occurs and the battery is not charged sufficiently, the alarm may not produce an audible sound.
  • Worn Alignment Guides: When there is wear and tear on the alignment guides, there is a greater risk that the connection pins will be bent and twisted, ultimately causing problems with electrical connectivity. This can cause the pump to stop and “cause death or serious injury,” the release indicates. Roughly 1 percent of distributed controllers have had worn alignment guides over the course of 18 months.
  • Power Management Software Upgrades: The alarm signaling the need for “battery switching” may go off prematurely when there is a temporary loss of communication between the controller and the batteries. HeartWare indicated that a software upgrade was being developed to correct this issue; the upgrade is expected to be available later in 2015.
  • Driveline Outer Sheath Discoloration and Cracking: There may be cracking and discoloration of the sheath protecting the driveline, which is the tube connecting the pump to the external controller and power source. The sheath contains a plastic material that may degrade when exposed to excessive amounts of ultraviolet (UV) light. This issue “could contribute to the risk of infection at the exit site,” according to the release. The sheath should be kept under clothing in order to minimize exposure to UV light.
  • Driveline Pulling and Snagging: The driveline may become damaged or disconnected when it is pulled or snagged, leading to electrical problems and pump stops. Serious injury or death may occur if the pump stops.

The recall was later updated to include the following information, according to a recall alert posted on the FDA’s website:

  • Damaged Alignment Guides/Connection Pins may Cause Pump to Stop (Added 6/16/15): HeartWare indicated it was aware of 33 cases of malfunction and one case of serious injury related to damaged alignment guides, which may cause pins to become twisted and may interfere with electrical connectivity.
  • Battery Failure may Prevent Alarm from Sounding (Added 6/19/15): Four reports were submitted to HeartWare involving failure of the battery powering an alarm in the controller. There were three injuries and one death reported, to date.
  • Damage to Driveline Connector may Cause Electrical Issues or Pump Stops (Added 6/19/15): Two reports of death and one report of serious injury were submitted involving damage to the driveline connector.

Need Legal Help Regarding HeartWare Device?

If you or someone you know has been implanted with a Heartware Ventricular Assist Device, you may have valuable legal rights. To find out more about filing a lawsuit or to receive a free, no-obligation legal consultation, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

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