The U.S. Food and Drug Administration on Tuesday issued a recall of a heart device made by a unit of Johnson & Johnson due to a faulty valve, following a recall by the company in June.
The valve, which prevents blood from flowing back through it, is part of a device used to insert and position cardiovascular catheters in the heart.
The unit, Sterilmed has not received any reports of adverse events due to the recalled devices, a Johnson & Johnson Medical Devices spokeswoman told Reuters.
About 110 Agilis Steerable Introducer Sheath devices made and distributed between Jan. 1 and May 5 are a part of the Class I recall, according to the FDA. (http://bit.ly/2lFe3N6)
Sterilmed said it had initiated a recall of the devices in June, and the issue had been fixed.
A Class I recall is the strictest form of recall issued by the health regulator, in situations where the use of faulty devices may cause serious injury or death.