The company began notifying customers of the product recall on April 2.
The FDA labeled the recall a Class I, the most serious type of recall issued by the federal watchdog, indicating that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The recall is related to several patient complaints in which gas flow cassettes of the device come loose due to the locking mechanism accidentally releasing during a change of system. The flaw may cause anesthesia gas to leak and can prevent the ventilator from supplying breathing support if not corrected immediately, according to the FDA filing.
A total 1641 units are affected by the recall, covering products with article numbers 66 77 200, 66 77 300 and 66 77 400, according to the FDA posting. The devices being recalled were manufactured and distributed between May 5, 2014 and July 7, 2015.
Marquet has received 10 device malfunction reports, but no injuries or deaths have been reported.
In April, The FDA issued a Class I recall of the TigerPaw II device that Maquet acquired in 2013. The recall followed an increase in reports of torn tissue on the left atrial wall and bleeding during use of the device, the FDA said.
Maquet acquired the device when it bought LAAx Inc. for an undisclosed amount in May 2013.