Unretrieved Device Fragments
The FDA receives almost 1,000 reports of device fragments being left in patients every year. This harmful procedure results in injuries and deaths, and almost always requires patients to undergo surgical procedures to have the devices removed.
Unretrieved device fragments, or UDFs, are fragments of medical devices and surgical equipment that remains in the patient after surgery. UDFs cause:
- Tissue reaction
- Infection
- Perforation
- Migration of the fragment
- Blood vessel blockage
- Death
The FDA is advising doctors and hospitals to follow device directions carefully, inspect devices for damage or fragmentation before and after use, and to discuss risks of UDFs with patients.