FDA Designates Medtronic Esophageal Device Issue as Class I Recall

The FDA has upgraded its classification of an issue with Medtronic and Given Imaging's esophageal pH monitoring capsule delivery device to a Class I Recall. This highest-risk classification indicates the device may not properly attach or detach, potentially due to a component problem exacerbated by improper handling. Medtronic had previously advised customers to remove certain devices, highlighting the serious risk of patient injury or death.