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FDA Issues Recall on J&J Heart Device

FDA Issues Recall on J&J Heart Device
(Copyright DPC)

Wednesday, 03 January 2018 05:36 PM

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.

© 2019 Thomson/Reuters. All rights reserved.

   
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The FDA 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.
heart, device, recall, fda, johnson
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2018-36-03
Wednesday, 03 January 2018 05:36 PM
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