Edwards Lifesciences recalls certain Fogarty Dilation Atrioseptostomy Catheters due to balloon deflation difficulties and fragmentation risks after deployment in pediatric heart procedures.
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
Edwards Lifesciences is recalling specific Fogarty Dilation Atrioseptostomy Catheters used in pediatric heart procedures. The catheters may have balloon deflation issues or fragment after deployment, potentially causing complications during heart surgery.
The catheter's balloon may not deflate properly after being deployed in a child's heart, or it could break off during use. This could lead to complications like blockages or injuries in the heart.
Pediatric patients undergoing heart procedures at medical facilities using the recalled catheters. Parents and caregivers of children with congenital heart defects are most at risk.
Check for the product code REF: 830705F on the catheter packaging. The catheters were sold between March 2019 and 15 months after that date.
Look for the product code REF: 830705F on the catheter packaging to confirm if it is recalled.
The catheter may have difficulty deflating after deployment or could fragment, potentially causing complications during pediatric heart procedures.
Check for the product code REF: 830705F on the catheter packaging. The catheters were sold between March 2019 and 15 months after that date.
The recall does not specify a remedy, so contact Edwards Lifesciences directly for guidance.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1116-2019 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-1116-2019 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.
