Flow-i Anesthesia Systems Recall Issued Over Possible Loss of Ventilation

More than 1,600 medical devices used to administer anesthesia are being recalled following reports that suggest that the gas flow vent may loosen, allowing anesthesia gas to leak and potentially resulting in improper amounts to be administered to patients. 

The FDA announced an Flow-i Anesthesia System recall this week, after at least 10 reports indicated that patient cassettes, which allow the gas to flow, loosened from the mount when users perform a system change. To date no injuries or deaths have been reported in connection with the device’s defect.

The Flow-I Anesthesia Systems are used to administer anesthesia while providing ventilation to patients with no or limited ability to breathe. The systems are used only by medical professionals in hospitals and can accommodate patients ranging from neonatal to adult.

FDA designated the anesthesia system recall as a Class I, which is the most serious type of medical device recall, suggesting that continued use of the product may pose a risk of serious adverse events or death. Since the cassettes provide the main flow for anesthesia and ventilation for breathing support, if the cassette is not properly attached it can cause improper amounts of anesthesia to be administered and create a suffocation hazard for patients.

The recall includes the FLOW-I Anesthesia Systems manufactured by Maquet Critical Care AB of Wayne, New Jersey that were distributed for sale to hospitals across the U.S. from July 7, 2014 to May 5, 2014. Maquet reported that 1,641 systems were sold and distributed to U.S. hospitals.

On April 2, Maquet Critical Care sent an urgent medical device field correction notice to cosignees to warn them of the recall and potential safety hazards. The notices included instructions to verify the serial number of the recalled devices and recommendations for a dislodged patient cassette. Maquet is currently having a representative contact consignees to arrange a replacement of the FLOW-i Anesthesia System patient cassette locking device.

Customers with questions regarding the recalled devices may contact a Maquet Service Representative or Maquet Technical Support at 1-888-627-8383. Health care professionals and consumers are also being encouraged by the FDA to report any and all adverse reactions or quality problems to Medwatch, the FDA’s adverse event reporting system.