Smiths Medical Recalls Implantable Ports, Warns of Endotracheal Tube Risks

Smiths Medical, now part of ICU Medical, has recalled specific ProPort implantable ports due to a manufacturing defect that may cause the plastic housing to separate from the port reservoir, with two injuries reported. Customers have been instructed to stop using and return the affected devices. Separately, the company issued an urgent medical device correction regarding its oral/nasal endotracheal tubes, warning that specific sizes may be smaller than expected, potentially leading to inadequate ventilation and severe health risks, including cardiopulmonary collapse or death.

ICU Medical has faced ongoing quality control challenges since acquiring Smiths Medical in 2022, including a pre-existing FDA warning letter related to manufacturing issues. Patients with implanted ports should be monitored for complications, and healthcare providers are advised to verify tube sizes before use. The company has guided on identifying affected products to mitigate potential patient safety risks.