Brief: FDA Provides Early Alert On Defibrillation Lead Issue From Boston Scientific
06/08/2025 15:52
Aug 6 (Reuters) - 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 ((Reuters.Briefs@thomsonreuters.com;))
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