FDA Public Health Notification: Unretrieved Device Fragments

Issued: January 15, 2008

Dear Healthcare Practitioner:

This is to advise you of serious adverse events associated with unretrieved device fragments (UDFs) and provide recommendations to mitigate these events. A UDF is a fragment of a medical device that has separated unintentionally and remains in the patient after a procedure. Patients may not be aware that this has occurred. The Center for Devices and Radiological Health (CDRH) receives nearly 1000 adverse event reports each year related to UDFs. These have included more than 200 different medical devices and numerous medical specialties.

To read the complete report please go to this link :

http://www.fda.gov/cdrh/safety/011508-udf.html