Class I Recall of Edwards Lifesciences Recalls Miller and Fogarty Atrioseptostomy Dilation Catheters

Published: 04/26/2019

  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

Edwards Lifesciences is recalling the Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter because of the possibility of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or detachment upon attempted retrieval. The firm has received reports of balloon fragmentation or detachment, which may cause serious adverse health consequences including: damage to the heart, the inferior vena cava, and/or the femoral and iliac veins; ad

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