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Class 1 Recall Issued for Defective Medtronic Devices

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Jarod Cassidy4 years ago

The U.S. Food and Drug Administration has issued a release notifying hospitals and distributors of a class 1 recall for defective guidewires manufactured by Medtronic Inc.

Medtronic Recalls Defective Guidewires

During heart procedures the guidewires are inserted through arteries in order to guide other devices, such as stents, into place.

According to the FDA release, the coating which allows the guidewires to slide through arteries more easily may break off, potentially creating a blockage in the blood vessel.

Medtronics has received four complaint reports so far. One patient suffered cardiac arrest, but was resuscitated.

Class 1 recalls are reserved for products with reasonable potential to cause serious injury or death.

Defective Guidewire Details

Following information provided by the FDA:

  • The recall affects approximately 15,000 units from specific lots of eight different product lines including:

    • Attain Hybrid guidewire
    • Cougar nitinol workhorse guidewire
    • Cougar steerable guidewire
    • ProVia crossing guidewire
    • Thunder extra-support guidewire
    • Thunder steerable guidewire
    • Zinger steerable guidewire
    • Zinger stainless steel workhorse guidewire
  • All recalled units were manufactured after mid-April of 2013.
Contact an Experienced Product Liability Attorney

Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of defective medications or pharmaceuticals, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.


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