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FDA Provides Early Alert On Defibrillation Lead Issue From Boston Scientific

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FDA:

  • FDA: PROVIDES EARLY ALERT ON DEFIBRILLATION LEAD ISSUE FROM BOSTON SCIENTIFIC

  • FDA: CERTAIN ENDOTAK RELIANCE DEFIBRILLATION LEADS WITH EXPANDED EPTFE COATED COILS MAY IMPACT SHOCK EFFICACY AND/OR REQUIRE EARLY REPLACEMENT

  • FDA: AS OF JULY 24, BOSTON SCIENTIFIC REPORTED 386 SERIOUS INJURIES, 16 PATIENT DEATHS ASSOCIATED WITH DEFIBRILLATION LEAD ISSUE- WEBSITE

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