The FDA has announced that Cook Medical is recalling its transseptal needles and transseptal needles with catheters due to complaints of rust being found on the solutions.
“Use of affected products could result in increased procedural time and inflammatory reactions, including systemic reactions which may lead to permanent impairment or death,” according to Cook Medical’s full announcement, which was published in full on the FDA website.
They products were all manufactured from October 2016 to July 2021. Customers have been sent letters that detail the situation and prepaid labels that can be used to return any affected products to Cook Medical.
The FDA has not yet classified this recall. There are no reports of injuries or illness related to this issue at this time, though there have been four complaints from customers.
Any adverse reactions that may be associated with this issue can be reported to both Cook Medical and the FDA.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.