Product Advisories

A Recall, Product Correction, Product Alert is a voluntary letter issued to inform Customers / End Users (health care professionals, patients, hospitals, retailers, wholesalers or distributors as appropriate) of an anomalous device behavior identified by Boston Scientific's Quality System. These categories are considered “Market Actions” and 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.

For further information and resources relating to TGA’s Procedure for Recall, Product Correction, Product Alert (PRAC), please visit:

Procedure for recalls, product alerts and product corrections (PRAC) | Therapeutic Goods Administration (TGA)

A Recall or a Non-Recall is a voluntary letter issued to inform respective persons / organizations (health care professionals, patients, hospitals, retailers, wholesalers or distributors as appropriate) of an anomalous device behavior identified by Boston Scientific's Quality System.  This 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.

For further information and resources relating to the MEDSAFE’s Procedure for Recall or a Non-Recall, please visit.

Product Recall Information