4th Class I Recall for Abbott HeartMate; Medline Sees Recall for Endotracheal Tube

The FDA has deemed two recalls as Class I — Medline Industries for issues with its Sub-G Endotracheal Tube and Abbott for yet another issue with its HeartMate 3 Left Ventricular Assist System.

This Class I recall is Abbott’s fourth for the HeartMate 3 system, this time for issues with the data displayed on the system monitor. Previous issues with the system include potential for blood leakage or air entering the seal interface between the left ventricular assist device inflow cannula and the apical cuff, unexpected start/stops and outflow graft obstruction.

Medline Industries Class I recall is for the company’s Sub-G Endotracheal Tube with Subglottic Suction which has the potential for detachment or tearing of the inflation tube.

The device has the potential for detachment or tearing which can result in cuff leakage, deflation, moisture buildup, and failure to inflate. If the device comes apart during use, partial or total airway obstruction and choking may occur, the FDA said.

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