(Reuters) - 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. (bit.ly/2A7nOIj)
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. (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.
Reporting by Manas Mishra in Bengaluru; Editing by Shounak Dasgupta