Edwards Lifesciences issued a recall of multiple lots of their Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter on March 28, which the US Food and Drug Administration now categorizes as Class I. That most severe recall classification means the faulty devices could cause serious injuries or death.
The catheters used in pediatric procedures are recalled "because of the possibility of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or detachment upon attempted retrieval," the FDA says.
It adds that Edwards has received reports of both complications, which pose a risk of serious adverse events including damage to the heart and vasculature, further procedures to remove the broken hardware, stroke, or embolism.
"One serious injury was reported in which an infant underwent an invasive but successful surgical procedure to retrieve a detached balloon. There were no deaths reported," the agency says.
The recall affects model numbers 830515F and 830705F manufactured from December 22, 2017 and distributed to providers January 9, 2018 to February 25, 2019.
All lots are due to expire within 15 months, the notice said; affected lot numbers and instructions for returning the devices are in the announcement.
Cite this: Edwards Recalls Miller and Fogarty Pediatric Cardiac Catheters - Medscape - Apr 29, 2019.