The Recall Desk

FDA (Devices) recall action 82455

Edwards Lifesciences, LLC recalled 2 products on 2019-05-01

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-05-01
Critical
1
Units
2,657

Why these products were recalled

Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • CriticalFDA (Devices)··2019-05-01

    Edwards Lifesciences Recalls Fogarty Dilation Atrioseptostomy Catheters

    Edwards Lifesciences is recalling Fogarty Dilation Atrioseptostomy Catheters due to reports of balloon fragmentation or detachment and difficulty deflating the balloon after deployment.

    Product
    Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an ac
    Category
    Distribution
    33 states
  • SevereFDA (Devices)··2019-05-01

    Edwards Miller Balloon Atrioseptostomy Catheter Recalled for Deflation Issues

    Edwards Lifesciences is recalling Miller Balloon Atrioseptostomy Catheters due to difficulty deflating the balloon and reports of fragmentation or detachment.

    Product
    Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The Miller balloon atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an accepte
    Category
    Distribution
    33 states