FDA announces Class 1 recall for implantable ports

Editor's Note

The US Food and Drug Administration (FDA) has deemed Smiths Medical’s recall of Proport Plastic Implantable Ports a Class 1, the most severe designation indicating serious risk of injury or death.

The devices are designed for repeated venous access for injections, infusions, and/or blood samples. According to the agency’s March 19 announcement, the recall was motivated by a manufacturing defect that may cause the plastic port housing and port reservoir to separate before, during, or after implantation. Two injuries and zero deaths have been reported.

Patients with an implanted device should be monitored for adverse events, and the housing and reservoir should feel secure and stable when palpating the portal, the agency advises. Customers and distributors should stop use and quarantine any inventory.