FDA Announces Class I Recall of Defective Anesthesia Systems

Medical device maker Maquet has warned that the company’s Flow-i Anesthesia Systems have a defect that “may cause anesthesia gas to leak and prevent the ventilator from providing breathing support if not corrected immediately.”

Maquet recalled the 1,641 units of its Flow-i Anesthesia Systems globally in April, including 80 in the U.S. The U.S. Food and Drug Administration (FDA) classified the recall a Class I in June, meaning that the agency believes “there is a reasonable probability that use of the device will cause serious adverse health consequences or death.” The FDA has received 10 reports of Flow-i Anesthesia System malfunctions, none of which resulted in injury or death, Fierce Medical Devices (FMD) reports.

According to last week’s alert viewed by FMD, “The firm (Maquet) has received several complaints where patient cassettes, which are the center of gas flow in the system, have come loose. The patient cassette locking device may accidentally release the patient cassette from its mount when users perform a change of system.”

Maquet sent its customers a recall letter that was obtained by FMD instructing them to inform staff who may use the Flow-i Anesthesia Systems of the patient cassette locking device issue. The company wrote that it will replace the faulty components, whose article and serial numbers are displayed in the recall notice.

A Class I recall for the Flow-i was also issued in 2012 due to a software issue caused the anesthesia system to switch between manual and auto ventilation modes. The latest recall comes on the heels of a permanent injunction from the U.S. Department of Justice (DOJ) that resulted in the halt of manufacturing at one of Maquet’s facilities, the suspension of five of its devices from the market and a $6 million fine. In April, the FDA announced the Class 1 recall of all 4,154 of the company’s stroke-fighting TigerPaw II left atrial appendage closure device, according to FMD.

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