Reported May 1, 2019 · Terminated
Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The…
Edwards Lifesciences, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only
- REF830705F
- Product UsageThe Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an accepted technique for palliation of several congenital cardiac defects. Description of Use Balloon atrioseptostomy can be performed in conjunction with diagnostic cardiac catheterization or under echocardiographic guidance and has been carried out after the diagnosis of several congenital cardiac
- defects including but not limited totransposition of the great arteries, total anomalous pulmonary venous drainage without pulmonary obstruction, tricuspid atresia, and pulmonary atresia with intact ventricular septum
- Lot codes and dates
- All lots within 15 months expiry from 03/01/2019
- Amount recalled
- 1093
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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