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Class 1 Recall Issued for Defective Medtronic Devices

Destiny Baker3 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.
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