Medtronic’s Sprint Fidelis defibrillation leads may possibly be linked to five deaths and several injuries. The company has taken the product off the market and is asking the medical community to return whatever leads they have in inventory.

Sprint Fidelis

The Sprint Fidelis model defibrillator is basically an electrical device used to counteract fibrillation of the heart muscle and restore normal heartbeat by applying a brief electric shock. The leads of the device are what’s being recalled as some may be defective and either provide too much of a shock or none at all – causing serious cardiac issues. However, there’s an even bigger problem:

There’s a shortage of alternative leads

Medtronic has said that the Sprint Fidelis leads would likely be replaced by Sprint Quattro leads. However, they don’t have enough on supply and won’t until later this year.

For now, the company, and the Food and Drug Administration (FDA), are not recommending that those patients who have the Fidelis leads implanted should have surgery to have the leads removed. They are recommending that patients see their doctors immediately to evaluate whether surgery to remove the lead or capping it is the most appropriate course of action. However, experts are saying that the procedure to replace the defective leads could be even more dangerous than the implanting surgery – something that is causing consumers angst.

Stock tumbles

Patients aren’t the only ones feeling angst. Medtronic’s stock tumbled over 10% following the company’s announcement to recall the leads. The company has half the market share of defibrillators and economists say that this situation is similar to a recall announced by Medtronic’s competitor, Guidant, in 2005.

Medtronic has already estimated that the recall will cause their second quarter revenue to drop $150 million to $250 million, the cost of the defective Fidelis inventory will cost approximately $15 million to $20 million in the second quarter alone and it estimates other costs related to the recall at $10 million to $20 million. If you or a loved one has been injured or died as a result of this device, contact an attorney immediately. To contact an attorney near you whose practice focuses in this area of law, click here.