Edwards Lifesciences recalls Miller Balloon Atrioseptostomy Catheters with risk of balloon fragmentation after deployment. Affected units have REF: 830515F and expired within 15 months of 03/01/2019.
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
Edwards Lifesciences is recalling Miller Balloon Atrioseptostomy Catheters due to reports of balloon deflation difficulties and fragmentation after deployment. This could lead to complications during pediatric heart procedures.
The catheter balloon may not deflate properly after deployment, causing blockages. In some cases, the balloon can fragment or detach, potentially causing serious complications during heart procedures.
Pediatric patients undergoing heart procedures at medical facilities using this catheter. Healthcare providers and pediatric cardiologists are most at risk.
Check for the product reference number REF: 830515F. The catheter was sold with an expiration date within 15 months of March 1, 2019.
Look for the reference number REF: 830515F and expiration date within 15 months of March 1, 2019.
The recall is due to reports of balloon deflation difficulties and fragmentation after deployment, which could cause complications during pediatric heart procedures.
The product reference number is REF: 830515F.
The catheter expires within 15 months of March 1, 2019.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1117-2019 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-1117-2019 from Edwards Lifesciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
