Edwards Lifesciences Recalls Miller Balloon and Fogarty Dilation Atrioseptostomy Catheters
UNITED STATES – According to an online article published by www.dicardiology.com, Edwards Lifesciences has recalled Miller Balloon and Fogarty Dilation Atrioseptostomy Catheters after receiving reports of difficulty in balloon dilation after deployment and subsequent balloon fragmentation or detachment.
Edwards Lifesciences manufactures the Miller Balloon Atrioseptostomy Catheter and the Fogarty Dilation Atrioseptostomy Catheter which are used to enlarge the opening between the atria of the heart in pediatric cardiac procedures. The catheters are used to improve a baby’s overall oxygen level as well as improve blood flow and cardiac output.
On March 28, 2019, Edwards Lifesciences issued a recall of certain lots of its Miller and Fogarty pediatric catheters after receiving reports of balloon fragmentation or detachment, which can pose a risk of injury or death to patients. Such injuries include, but may not be limited to: damage to the heart, damage to the inferior vena cava, damage to the femoral and iliac veins, the need for additional procedures to retrieve fragments, permanent injuries that result in patient disability, pulmonary embolism, stroke, damage to other organs, and death. So far, one serious injury has been reported, but no deaths have been reported.
Specific Recall Information
The recall issued by Edwards Lifesciences has been classified as Class I by the United States Food and Drug Administration (FDA), which means that a medical device poses a risk of serious injury or death to patients. The recall includes model numbers 830515F and 830705F (which encompasses multiple lot numbers provided on the FDA’s website). The affected lots were manufactured between December 22, 2017, and January 18, 2019. The affected lots were distributed between January 9, 2018, and February 25, 2019.
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