Learn more about how to handle recalls at the Medical Device Recalls: Current Topics & New Initiatives | June 24-25, 2019 | Attend in Washington, D.C. or virtuallyOn Friday FDA announced an Edwards Lifesciences Class I recall of the company’s Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter that were manufactured between December 20, 2017 and January 18, 2019. The catheters are used to enlarge the atria (the two upper chambers of the heart). However after the balloon is deployed, there is a risk of fragmentation or detachment when trying to retrieve the device. This malfunction can cause series adverse events, including damage to the heart, inferior vena cava or the femoral and iliac veins, permanent patient disability, pulmonary embolism, stroke, organ damage and death. In addition, procedures to retrieve the fragments can also lead to adverse events. Although no deaths have been reported, a serious injury to an infant occurred and an invasive procedure had to be performed to retrieve the detached balloon.
The recall affects product model numbers 830515F and 830705F and all lots expiring within 15 months.
Edwards sent an Urgent Product Recall notice to affected customers on March 28 (also the date in which the recall was initiated), instructing them to remove any affected products from inventory and return them to customer service.