What Is an ICD Recall?
An ICD manufacturer issues a "recall" when it discovers that a certain subset of its ICDs are prone to behaving outside of design expectations, in a way that may possibly affect the safety of patients who have those devices. When a recall is issued, patients with the affected ICDs usually receive a letter from the manufacturer, and they often see breathless news reports about the recall. All this can be pretty scary, but often, the scariest thing about an ICD recall is the word "recall" itself."Recall," when it comes to ICDs, does not mean what you think it means. It usually does not mean that your ICD needs to come out. Instead, it means that you and your doctor need to check your device, discuss the issue that triggered the recall, and decide which course of action is best for you. This all requires the careful consideration of several important factors, which we will discuss shortly. But first, why is it called a recall when most affected devices don't really need to be "recalled?"
The word recall is required in this situation by a federal statute -- a statute that was written back in the day when medical devices were rarely implanted. It is easy to "take back" a non-implanted medical device and replace it with another one, just to be safe. It is not so easy, or necessarily safe or smart, to do so when the devices are implanted within somebody's body; exchanging it would require surgery. The fact is, most recalled ICDs can be safely left in place and managed in some other way -- perhaps by programming small changes in how the device functions, doing more frequent follow-up, or even using wireless "remote" follow-up.
Most doctors, and the FDA itself, find the word "recall" when applied to ICDs to be unfortunate and unnecessarily anxiety-provoking, and would rather use another word (such as "advisory"). But in this case, it actually would take a literal Act of Congress to change the language.
The bottom line is that a "recall" does not necessarily mean - and usually does not - that you need a new ICD. It does mean that you and your doctor need to have a long talk.
What Triggers A Recall?
As mentioned, a recall is issued when a subset of ICDs are found to behave outside their design expectations. This is a polite way of saying that when a subset of ICDs is recalled, it is usually because those ICDs appear to have a risk of failure that is higher than the predicted failure rate, or because some type of device failure has been identified that, should it occur, would pose a particularly high risk to the patient.An ICD generator is an extraordinarily complex device. It contains hundreds of delicate electronic components, housed in a small metal "can," along with a sophisticated battery and a powerful capacitor. The ICD is expected to survive for up to six or seven years in an extremely hostile environment, that is, inside the human body, which is a high-temperature, salt water environment that would ruin most electronic devices within minutes. The ICD is expected to remain entirely quiet for up to several years at a time as it inobtrusively monitors the heart rhythm. If a life-threatening arrhythmia occurs, it is also expected to react immediately with a life-saving shock. That such a device has been successfully built is itself an amazing feat of engineering. But the complexity of the ICD generator means that, theoretically at least, there are literally hundreds of possible ways for these devices to "fail."
When a manufacturer submits a new model of ICD to the FDA for approval, one of the documents it must include is a "failure prediction," which is an engineeering analysis that predicts how likely that type of ICD is to fail (for one reason or another) over a five-year period. This analysis is based on the likely failure rate of each of the hundreds of components that go into the device. The fact that the predicted failure rate is never zero does not mean that ICD manufacturers are lax or cutting corners. To the contrary, they always are working to improve the safety of the devices they build. No device made by man is ever perfect and entirely free of the risk of failure. ICD manufacturers are expected to predict that failure rate -- and then live up to it.
In the past few years, the predicted failure rate for a typical modern ICD has been around 1% to 2% over five years. This stacks up very favorably with older ICDs (which had failure rates of roughly 8% to 20% over three to four years during the 1990s, and as high as 50% over two years in the 1980s).
So in general, an ICD recall usually indicates either that:
- The projected risk of failure is higher than the 1% to 2% five-year failure rate that applies to most devices.
-or- - A type of failure has been identified that, if it occurs, would place the patient at a particularly high risk.
