FDA designates Class 1 recalls for aspiration catheter, infusion accessory, endotracheal tubes

Editor's Note

The US Food and Drug Administration (FDA) has issued three Class I medical device recalls—the most severe category indicating risk of serious injury or death—for Q’Apel Medical Inc.’s HIPPO 072 Aspiration System and Cheetah catheter, Fresenius Kabi USA’s Blood Products Administration Set with 200 Micron Filter, and Medline Industries, LP’s convenience kits containing the Teleflex Humid-Vent Mini HME.  

Q’Apel Medical Inc. reportedly issued the HIPPO 072 recall following FDA concern about the distal tip of the aspiration catheter when removing a clot during aspiration. Used to remove clots from blood vessels during neurovascular procedures, these devices may fragment during use, leaving broken pieces. As of the recall date, there were four reported injuries and one reported death associated with the HIPPO 072. No injuries or deaths were reported for the Cheetah catheter. The full FDA report includes product codes, lot numbers, and return instructions.

The recall of the Fresenius Blood Products Administration Set with 200 Micron Filter, used for the intravenous administration of blood products via infusion pumps, was motivated by potential leaks. Risks include blood loss, contamination, and interruption of therapy. As of the report date, no injuries or deaths had been reported. Instructions for identifying and returning affected product lots are provided in the FDA's full recall notice. 

The Medline neonatal and pediatric convenience kits include the Teleflex Humid-Vent Mini HME, which may have an occluded filter that could block airflow to patients, potentially resulting in hypoventilation or death. While no injuries or deaths have been reported as of the recall date, the FDA determined the issue poses a significant risk to patient safety. Medline’s recall instructions to affected customers are detailed in the full FDA report.