Medtronic’s recall of their
Sprint Fidelis defibrillator lead is causing some consumers to panic. While the company has said that only a small percentage of the leads may be defective, those that have them implanted may feel as though they are playing Russian roulette.
Not your ordinary recall
The onslaught of recalls these days has made us all a bit complacent about new ones. However, most recalled products can simply be taken off the market, thrown away or returned to the manufacturer.
That’s not the case here. While Medtronic is asking doctors, or anyone else, with a lead that has not been implanted to return it, there are over 200,000 patients that simply can’t do that. Health experts say that trying to remove the leads can be a very risky surgery and the Food and Drug Administration (FDA) has said that there is no test to determine which leads might be defective – a scary proposition for patients with the device.
What Medtronic is and isn’t doing
Medtronic has said that, in addition to the recall, it will cover the cost of a replacement lead for those that have fractured, plus up to $800 in medical expenses that are not covered by insurance. However, the company has said that it will not pay for procedures to replace functioning leads that patients want taken out to head off possible problems in the future.
What did Medtronic know – and when did they know it?
The question on everyone’s mind is ‘What did Medtronic know – and when did they know it?’ According to reports, the company knew about the problem in March of 2007, but only issued minor warnings and did not recall the product at that time. It was only later that the company said it received further validation that the leads may in fact be dangerous. Since the devices are used by those who have cardiac issues, experts are speculating that perhaps injuries not originally associated with these devices may now become suspect.
If you or a family member have been injured or died as a result of this device, contact an attorney who can evaluate your case. To contact an attorney near you whose practice focuses in this area of law, click here.
