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Class I Recall Issued for Maquet's FLOW-i Anesthesia System

Jul 7, 2015

Maquet's FLOW-i Anesthesia Systems have an issue that stops the ventilator from providing adequate breathing support, the U.S. Food and Drug Administration (FDA) warned. The FLOW-i is used in hospitals to administer anesthesia and breathing support to patients; it is intended for a variety of patients, from neonatal to adult.

According to the FDA recall notification, there have been reports of problems with the patient cassettes that may ultimately "cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately." The patient cassettes are the center of gas flow in the system. Maquet has received reports of instances where the cassettes have come loose. This may occur when users change patient tubing or replace the CO2 absorber, inadvertently causing the locking device to release the patient cassette from its mount. There have been 10 reports of malfunction, with no injuries or death, thus far.

The recall was initiated in April and affected 1,641 units worldwide. In the United States, 80 units are affected. The FDA classified the recall as Class 1 in June, which is the agency's most serious recall status. Class 1 recalls indicate that exposure to the recalled device could reasonably lead to serious injury or death.

The recall is only the latest in a string of troubles for Maquet, Fierce Medical Devices reports. Earlier this year, the Department of Justice issued a permanent injunction that forced one of its facilities to stop manufacturing, suspended 5 of its devices and resulted in a $6 million fine. The company also faced another Class 1 recall over its stroke-fighting TigerPaw System II left atrial appendage closure device in April.

According to Fierce Medical Devices, this is not the first time the Flow-i system has been under Class 1 recall. In 2012, a recall was issued because the system inadvertently switched between manual and auto ventilation modes due to a software issue.

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