Two messages taught by recent cardiac device recalls

Cardiac devices were in the news today. And you guessed it; the reports centered on problems.

In this case the story includes dramatic visuals. The St Jude defibrillator wire, Riata, a commonly-used wire has been ‘recalled’ by the FDA because of electrical failures in at least 10% of cases. The dramatic part here includes the fact that internal wires can become ‘externalized‘ in the body. That’s medical speak for bare metal getting exposed inside the heart!

A very detailed summary on goes over the minutes of an expert panel. It’s very early in the natural history of this problem, so neither I nor the experts know what to do. We are at a scary moment for some: there aren’t guidelines.

It would be beyond the scope of this blog to cover the medical details of an extremely complex ICD issue.

Rather, two thoughts come to mind. Thoughts that apply in a general sense to heart disease and doctoring.


The act of implanting cardiac devices constitutes serious business. Man-made devices will always harbor flaws.This recall, along with the recent Sprint Fidelis lead (Medtronic) recall shine an important light on the whole idea of treating heart disease after the fact. These ‘limitations of technology’ only strengthen my argument for prevention. Decreasing the number of heart attacks and treating high blood pressure over the long-term would dramatically lower the number of people exposed to the risks of implanting complicated hardware into the body.

Role of judgement:

The second thing that these connundrums highlight is the important role of judgement. There are no protocols, no evidence-base, no guidelines, and in this case, not even a consensus. Doctors have to read about the problem, assess how the problem could affect their patient and then discuss options with the patient. There’s not a right answer. Dealing with this problem takes horse-sense, mastery-of-the-obvious, gumption and humility. This challenge, I find refreshing.