Cook Medical recalled Oct. 19 all lots of its transseptal needles after receiving complaints of rust on some of the needles.
The recall includes all lots of both its transseptal needles and transseptal needles that come with a catheter. The Bloomington, Ind.-based company said rust has been found both internally and externally on the needles.
Using a needle with rust on it could result in inflammatory reactions or systemic reactions that could lead to permanent impairment or death, the company said in a news release. The FDA has not classified the recall.
Cook Medical said it hasn't received reports of injury or death stemming from the rust on the needles, but has gotten four complaints of rust being noticed before the needle was used on a patient. The company warned that the rust may go undetected by a user.
Read the full news release here.