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FDA: Faulty Medtronic heart devices can kill

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Federal health officials say defects in some Medtronic devices used in heart procedures could cause serious injury or death.  

After Medtronic received reports of four problems, including one involving a patient who went into cardiac arrest but was resuscitated, on Oct. 21 the Food and Drug Administration issued a warning about 15,000 of the company's guidewires.  

Doctors insert them through patients' arteries to guide other devices into place, such as stents that hold open blocked arteries. A coating on the guidewires may break off and block a blood vessel. FDA officials say the product has the potential to cause serious injury or death.

  Medtronic has stopped shipping the wires and asked hospitals and distributors to quarantine all potentially affected units and return them to the company. 

  Company officials say the recall does not include defibrillators, stents or pacemakers implanted in patients. 

  Problems with the guide wires can be reported to Medtronic by calling 877-526-7890 during weekdays from 8 a.m. to 5 p.m. Central Standard Time.

  Adverse reactions or quality problems can be reported to the FDA.