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Guidewire Recall & Defective Guidewire: Coating May Delaminate And Detach

Written by Joseph Lyon on . Posted in Medical Device Litigation.

Ohio Medical Device Lawyer reviewing Defective Guidewire Recall Issued due to reported injuries and complications

“Medtronic, Inc. announced that FDA has classified the company’s recently initiated voluntary field action related to certain a defective guidewire.”

Medtronic has been involved in numerous lawsuits due to injuries resulting from faulty medical devices put to market without proper safety risk warnings or proper pre-approval testing. Medical device companies have a duty to ensure the safety of patients.

“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.”

“The guidewires covered by this defective guidewire recall are designed to facilitate percutaneous coronary interventions or the placement of left ventricular leads for cardiac rhythm devices. The defective guide wire recall includes 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

Additional information about the recall, including the lot numbers of affected product, is accessible through the Medtronic website – specifically,  Http://www.medtronic.com/for-healthcare-professionals/index.htm1. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Medical device companies should be held accountable for the defective products they release to the market. When an injury or preventable death occurs, a product liability lawsuits can be filed on behalf of plaintiffs to recover compensation.

Joe Lyon is a highly-rated Cincinnati catastrophic injury lawyer and Ohio product liability attorney investigating claims and accepting cases nationwide when defective Medtronic products injure patients. If you have questions regarding the defective guidewire recall and your legal options, please contact the Lyon Firm.