​Edwards—Miller Balloon and Fogarty Dilation Atrioseptostomy Catheters: Balloon Deflation May Be Difficult after Deployment; Balloon Fragmentation or Detachment May Occur

April 3, 2019 | Strategic Insights for Health System


​ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at clientservices@ecri.org.

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...

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