Faulty Medical Devices Recall by Medtronics: FDA Issues Class 1 Status

Cartwright - November 18, 2013 - Blog, FDA Alerts

As a consumer alert on faulty medical devices, The Cartwright Law Firm wants to warn consumers who may have had a cardiac rhythm device implanted to be aware of the following issue: Medtronics, Inc. issued the following press release under urging from the FDA in response to what the FDA terms a Class 1 recall:

“FOR IMMEDIATE RELEASE – MINNEAPOLIS – Nov. 15, 2013 – Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company’s recently initiated voluntary field action related to certain guidewires as a Class I recall.

Based on an internal investigation following a limited number of complaints, including one patient injury, Medtronic began notifying hospitals and distributors worldwide the week of Oct. 21 that some models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach. The notification requested that all potentially affected units be quarantined immediately and returned to the company as soon as possible for credit and replacement.

Medtronic has also taken the necessary steps to prevent future shipments of the recalled products and notified regulatory agencies around the world as appropriate.

The FDA defines a Class I recall as a situation in which there is a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death.

The guidewires covered by this recall are designed to facilitate percutaneous coronary interventions or the placement of left ventricular leads for cardiac rhythm devices. They include specific lots from the following eight product lines that were manufactured after mid-April 2013:

  • Cougar nitinol workhorse guidewire
  • Cougar steerable guidewire
  • Zinger stainless steel workhorse guidewire
  • Zinger steerable guidewire
  • Thunder extra-support guidewire
  • Thunder steerable guidewire
  • ProVia crossing guidewire
  • Attain Hybrid guide wire”

Reports to the FDA have shown several injuries, and one near fatality, when the coating from the guidewire broke off and cause a cardiac event that the patient barely survived. Anyone who fears they may have had any one of the above faulty medical devices used during the course of their surgeries should speak to their doctors immediately. And if your surgery did employ any of these products, call the highly experienced medical device attorneys at The Cartwright Law Firm for a free consultation about your rights should you experience injury due to these products. Call us today at 415-433-0444.

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