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FDA Orders Recall of Medtronic Heart Guidewires

Recall of Heart WiresThe Food and Drug Administration has classified the recently recalled guidewires manufactured by Minneapolis-based Medtronic, Inc. as potentially fatal. These guidewires are used in heart procedures.
The FDA admits to having received complaints from patients about these guidewires. The latest estimates from the FDA place the number of recalled heart guidewires at 14,896 from 181 different lots.

The recall of the ATTAIN HYBRID wires and Interventional Wires began in October. This is when Medtronic started the recall after having received complaints from four different patients. One of the patients sustained injury because of these faulty guidewires.

After reviewing the different reports and doing its own research, theFDA deemed this a Class I recall – this means that the FDA believes there is a reasonable probability that the exposure to or use of that particular product will lead to serious health issues or possibly even death.

What is the problem with these heart leads?

The problem is that the coating of the wires may detach. If that happens, it may produce clots. Those clots may lead to a heart attack or stroke. These guidewires are implanted into an artery to help guide a catheter in the event of a heart attack. By opening up blood flow with a stent or other device, it is possible for the patient to survive an otherwise possibly fatal heart attack.

This is not the first time that Medtronic has dealt with product recalls either. In 2007, the company recalled the Sprint Fidelis defibrillation leads. The use of these leads could lead to serious injuries or possibly even death because of the potential for lead fractures. There were also additional recalls that go back several decades.

The different Medtronic product lines included in the recall are:

  • Attain Hybrid Guidewire
  • Thunder Extra-Support Guidewire
  • Zinger Stainless Steel Workhorse Guidewire
  • Thunder Steerable Guidewire
  • Cougar Steerable Guidewire
  • ProVia Crossing Guidewire
  • Cougar Nitinol Workhorse Guidewire
  • Zinger Steerable Guidewire

It is possible to find more information about specific model numbers on the company’s website. According to Medtronic, these guidewires are used for the placement of left ventricular leads for cardiac rhythm devices or to support percutaneous coronary interventions.

Receiving compensation for a defective heart lead

Despite the fact that it may be scary to learn you or someone close to you may have issues with a recalled product, it is important to act fast. If you or someone close to you suffers injuries or other damages because of a recalled product, you may be entitled to compensation.

In the event that you are affected by this recall, it would be in your best interest to discuss your case with a Chicago Medical Device Defect Attorney who specializes in liability rather than simply accept a settlement from a company. It would be beneficial to discuss your possible case with a legal professional in order to have some feedback or understanding of what your legal options are.