Edwards—Miller Balloon and Fogarty Dilation Atrioseptostomy Catheters: Balloon Deflation May Be Difficult after Deployment; Balloon Fragmentation or Detachment May Occur
April 3, 2019 | Risk Management News
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In an Urgent Product Recall letter submitted by an ECRI Institute member hospital, Edwards states that balloon deflation of the above catheters may be difficult after deployment. Edwards also states that it has received reports of balloon fragmentation...