Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The Miller Balloon catheter and Fogarty dilation cath are designed to be used to enlarge the opening between the two upper chambers of the heart either to increase oxygenated and deoxygenated blood mixing to improve a baby’s overall oxygen level or to decompress one of the atria when drainage is obstructed to improve blood flow and cardiac output, the federal watchdog said.
The agency said that Irvine, Calif.-based Edwards is recalling the devices due to the possibility of difficulty in balloon deflation after deployment which could lead to fragmentation or detachment of the balloon during attempted retrieval.
The FDA said that Edwards received reports of the balloon fragmenting or detaching, which may cause serious adverse health consequences. Possible complications include damage to the heart, the inferior vena cava and/or the femoral and iliac veins, additional follow-up procedures to retrieve fragments, permanent patient disability, pulmonary embolism, stroke, damage to organs and death.
A single serious injury has been reported in which an infant underwent an invasive, but successful, surgical procedure to retrieve a detached balloon. No deaths have been reported so far related to the issue, according to the report.
The recall affects Miller Balloon atrioseptostomy catheters and Fogarty dilation atrioseptostomy catheters with model numbers 830515F and 830705F under 60 different lot numbers, all set to expire within 15 months. Affected devices were manufactured between December 22, 2017 and January 18, 2019 and distributed between January 9, 2018 and February 25, 2019, according to the FDA release.
Edwards Lifesciences began contacting users of the devices instructing them to identify and remove affected products.
Last week, Edwards Lifesciences saw shares fall despite the medical device maker posting Street-beating first quarter earnings results that saw the growth on the bottom line of over 20%.