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FDA Issues Early Alert On Watchman Access System Issue From Boston Scientific

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US Food & Drug Administration:

  • FDA: ISSUES EARLY ALERT ON WATCHMAN ACCESS SYSTEM ISSUE FROM BOSTON SCIENTIFIC

  • FDA: AS OF JULY 30, BOSTON SCIENTIFIC HAS REPORTED 120 SERIOUS INJURIES AND 17 DEATHS ASSOCIATED WITH WATCHMAN ACCESS SYSTEM ISSUE

  • FDA: BOSTON SCIENTIFIC HAS ISSUED A LETTER TO AFFECTED CUSTOMERS RECOMMENDING CERTAIN WATCHMAN ACCESS SYSTEMS HAVE UPDATED USE INSTRUCTIONS

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