April 30, 2019

FDA: Class I recall of Miller and Fogarty Atrioseptostomy Dilation Catheters

By: Judy Mathias
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Editor's Note

The Food & Drug Administration (FDA) on April 26 identified the recall of Edwards Lifesciences' Miller and Fogarty Atrioseptostomy Dilation Catheters as Class I, the most serious.

The recall was initiated because of reports of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or detachment on retrieval.


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The catheters are used to enlarge the opening between the two upper chambers (atria) of the heart.

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