Class I Recalls for Arrow Cardiac Balloon Catheters, Getinge Anesthesia Vaporizers

A part of an anesthesia system from Getinge that may dispense toxic gas and a cardiac balloon catheter from Teleflex/Arrow that may overtwist during use are both the subject of recalls that the FDA has deemed as Class I, the most serious recall as use of the devices may result in injury or death.

Getinge’s Vaporizer Sevoflurane Maquet Filling is part of the company’s Flow anesthesia systems, including Flow-i C20, C30, and C40 as well as Flow-c and Flow-e. The device contains, vaporizes, and blends liquid sevoflurane with oxygen to start and maintain general anesthesia. Abbvie, Baxter, and Piramal produce different formulations of sevoflurane, however the issue has only occurred with low water content sevoflurane from Baxter and Piramal, the FDA said.

Teleflex, and its subsidiary Arrow International found a manufacturing error that may cause the catheter’s balloon to become overtwisted — a problem that “can sometimes be identified visually, but a device may still be impacted even if the issue cannot be detected visually,” the FDA said in its recall notice. “This issue may: prevent the balloon from fully inflating, cause blood to back up in the tubing, allow helium to leak, and lead to catheter damage or insertion difficulty during use,” the FDA explained.

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