FDA: Medtronic Stops Production and Distribution of Troubled HeartWare VAD
Medtronic and FDA say new implants should stop immediately and advise use of other commercially available durable LVADs.
In a letter to healthcare providers, the US Food and Drug Administration said today that Medtronic has ceased the sale and distribution of its HeartWare ventricular assist device (HVAD) system. The action was taken due to a higher frequency of neurological adverse events and death compared with other commercially available durable left ventricular assist devices (LVADs).
Medtronic issued its own letter advising physicians to stop new implants of the system. Both the company and the FDA say there have been more than 100 complaints involving a delay or failure to restart of HeartWare’s internal pump, which led to 14 deaths and 13 pump removals. The FDA had previously initiated a Class I recall of the pump implant kit for failure to initially start or to restart. That was followed by a second Class I recall for the HVAD battery cables, data cables, adapter cables and controller 2.0 ports.
Physicians are advised to continue with existing procedures and protocols for the device in patients who currently have an implanted HeartWare pump and to “contact Medtronic for necessary replacement of peripheral components (for example, controllers, batteries, AC/DC adapters, carrying case), which will continue to be made available by Medtronic,” according to the FDA’s letter.
“For new left ventricular assist devices (LVAD) implants, use an alternative, such as the Abbott HeartMate 3 LVAD instead of the Medtronic HVAD System,” the FDA adds. However, the agency stresses that elective removal of HeartWare is not recommended at this time and that physicians should relay that information to patients. “In general, the risks associated with explant will outweigh the potential benefits. Decisions about removing and/or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks.”
The agency says it will continue to monitor the safety and efficacy of HeartWare systems in patients who currently have them implanted.