Product Advisories

Product Advisory is a voluntary letter issued to inform physicians of an anomalous device behavior identified by Boston Scientific's Quality System.

A Product Advisory is issued when there is a material elevation in risk to patient safety with potential for compromised lifesaving therapy, or when Boston Scientific can provide meaningful guidance to improve patient outcomes or device performance.

Current Product Advisories

Note: The France Field Safety Notice (physician letter) is slightly different than the US physician letter.  There are minor differences, which are there to comply with EU MDR (last page has table of Affected Products with Model and GTIN), and in response to minor change requests from ANSM (French Competent Authority).  
Top