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.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a Class I medical device with reports of device failure (fragmentation/detachment) during a critical procedure, which meets the criteria for a Severe rating due to the risk of significant injury.
Plain-English summary
Edwards Lifesciences, LLC is recalling the Miller Balloon Atrioseptostomy Catheter (REF: 830515F). The recall involves 1,564 units distributed worldwide, including across the United States and numerous foreign countries. The affected lots are those with an expiry date within 15 months from March 1, 2019.
The recall was initiated because of difficulty with balloon deflation after deployment, as well as reports of balloon fragmentation or detachment. This device is a prescription-only medical product used in pediatric cardiology to enlarge interatrial openings for the palliation of congenital cardiac defects.
Healthcare providers and patients should contact Edwards Lifesciences for further instructions regarding the return or replacement of the affected devices.
The recalled product
- 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
- Manufacturer
- Edwards Lifesciences, LLC
- Affected units
- 1,564
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within 15 months expiry from 03/01/2019
Distribution
Part of a larger recall action
This product is one of 2 recalled by Edwards Lifesciences, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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