Medtronic and FDA Face Scrutiny on Sprint Fidelis Recall and Safety Issues

Source | Wall Street Journal

By ANNA WILDE MATHEWS and THOMAS M. BURTON

Medtronic Inc.’s decision to stop selling potentially defective defibrillator leads has prompted scrutiny of the devices and of how safety concerns about them were handled by the company and the Food and Drug Administration.

Plaintiffs attorneys, a consumer group and Iowa Sen. Chuck Grassley are examining the history of the Sprint Fidelis leads, which are electrical wires that connect the hearts of patients to the defibrillators implanted in their chests.

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Learn More About the Medtronic Sprint Fidelis Recall 

Medtronic has suspended sales of the Sprint Fidelis® family of defibrillator leads because of the potential for lead fractures, reports of at least 5 patient deaths and other serious, life-threatening complications.

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Medtronic Recall Information

Sprint Fidelis Recall Information