Update on Cook Medical’s Recall of Transseptal Needles

The FDA has issued on update on Cook Medical’s Oct. 8 recall of its transseptal needles, including transseptal needles with catheters.

The agency said it has not yet classified the recall, which was prompted by the potential for rust inside and outside the products used for left-heart access in diagnostic and interventional procedures. The affected products were manufactured between Oct. 2, 2016, and July 22.

Use of the potentially rusted needles could result in inflammatory reactions, including systemic reactions that may lead to permanent impairment or death, the agency said. The company has received four complaints so far, although there have been no reports of injury or death.