The U.S. Food and Drug Administration (FDA) announced a Class I recall of Smiths Medical's ProPort plastic implantable infusion port. The FDA noted that some ProPort devices may experience separation of the plastic port body from the reservoir before, during, or after implantation due to manufacturing defects.

Level 1 recall is the most serious recall level, applicable to medical devices where "continued use may cause serious injury or death." The FDA warns that using defective products may lead to the following risks:

• complications resulting from delayed or interrupted emergency treatment;
• Chemotherapy and other intravenous drug leaks causing skin or tissue damage, scars at the implant site;
• Air enters the blood causing air embolism;
• death

As of now, the FDA has received two injury reports, with no fatalities.

ProPort plastic implantable infusion port is part of the venous access system, including a plastic infusion port, silicone or polyurethane catheter, catheter connector, Port-A-Cath needle, blunt needle, and vein picker. The system is suitable for patients requiring repeated intravenous injections, infusions, or blood draws.

FDA recommends that healthcare facilities take the following measures:

closely monitor the patient: check if there is swelling, redness, or discomfort at the implant site (which may indicate leakage or system failure);

Palpation to confirm stability: Ensure the port body is securely connected to the fluid reservoir through palpation;

Timely report adverse events: submit a report immediately through the MedWatch system upon discovering any anomalies.