Last year, medical devices manufacturer Medtronic bought HeartWare, the company behind a heart pump known as the HVAD system. The deal cost Medtronic $1 billion.
Prior to the purchase, HeartWare had received not one, but two safety letters from the U.S. Food and Drug Administration over issues related to the HVAD pump. These letters detailed agency concerns over the effects of moisture on the HVAD system. Medtronic was aware of this while courting the purchase of HeartWare.
HVAD works by using a small magnetic motor-like device that is implanted near the patient’s heart to circulate blood after their own heart has failed. The unit also includes a controller and battery back; both of which remain outside of the patient’s body. Each device is sold for over $100,000.
In response to those safety letters, HeartWare issued a global safety alert detailing the fact that almost 9,000 HVAD external control units were equipped with connectors that could come loose and allow moisture to seep into the unit. This could, in turn, cause the unit to cease to function or make alarms harder to detect. In the worst case, the effect could be likened to someone hitting the off switch on a patient’s heart.
Those safety letters have now become an FDA recall. Late last month, the FDA issued a Class I recall on two models of HVAD pumps. The Class I recall is the agency’s most grave and is reserved for those situations that have a higher likelihood of causing serious harm or death to product users.
HeartWare had already begun working to inform doctors of problems with HVAD units prior to the recall. In letters sent in May and August of this year, the company explained the situation and the potential for harm. Doctors were advised to inspect patient controllers and replace them as necessary; however did not state that the issue warranted particular urgency. Such checks could be conducted during routine checkups and visits and did not require an additional appointment to be scheduled specifically to address the issue. The August letter asked for as-yet un-implanted units to be sent back to the company.
The lack of urgency surrounding what is now a Class I recall is troubling, particularly because at least one death has already been attributed to fluid getting into the controller of a Medtronic/HeartWare HVAD unit. The moisture caused a short circuit and the device failed.
Most doctors have acknowledged receipt of the safety alerts regarding Medtronic HVAD units. However, patients implanted with heart pumps are encouraged to ask their doctor if their pump is one of nearly 9,000 at risk of encountering this potentially fatal flaw.