FDA announces new recall of instructions for Medtronic’s HVAD system after 1 death, 64 injuries
The FDA has announced that Medtronic is recalling the instructions for use and patient manual that accompany certain parts of its HeartWare Ventricular Assist Device (HVAD) system.
This is a Class I recall, which means the issue can lead to serious injury or death. One death and 64 injuries have already been reported to the FDA.
Updated instructions for use and patient manuals have already been finalized and are being sent out to all affected customers, the FDA noted in its announcement.
Safety issues related to the HeartWare HVAD system’s carrying case, driveline cover and controller power-up sequence are at the center of this recall. Dropping the carrying case, for instance, can damage the case and interrupt pump power. The instructions for use and patient manual have been updated to include new details about this potential scenario.
The driveline cover, meanwhile, can be inadvertently put on backwards by the patient, an issue that will has been addressed in the updated patient manual. Also, the LED lights on the controller that turn red when the system powers up may be mistaken as a serious alarm, even though that is not what those lights indicate. This has been emphasized specifically in the updated documentation.
The recall includes more than 130,000 different devices distributed in the United Sates from March 2006 to the present. Specific components affected by the recall include the HVAD pump, controller, AC adapter, DC adapter, data cable and battery pack.
Medtronic first initiated the recall on Feb. 26, sending an urgent notice to every customer that may have been impacted.
More information from the FDA is available here.
Read about a previous Class I recall related to the HeartWare HVAD system here.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.