The FDA designated an Endologix (NSDQ:ELGX) warning over a catheter introducer as a Class I recall, meaning the device could seriously injure or kill patients.
The Irvine, Calif.-based company received reports that the dilator component of its AFX introducer system can break off during procedures.
Endologix sent a letter to customers in Florida, Indiana, Michigan, New Hampshire, New Jersey and New York, the only states where the defective introducer system was distributed.
The FDA warned that "use of this recalled product may cause serious adverse health consequences, including death."
Endologix said it will call each customer to confirm the location of any affected systems and come to remove it. The original warning letters went out May 13, but on May 21, Endologix discovered another affected device and sent a letter to that company as well, according to the watchdog agency.