FDA Issues Class I Recall for Boston Scientific ENROUTE Catheters

The U.S. Food and Drug Administration (FDA) has classified Boston Scientific's removal of certain Percutaneous Catheters as a Class I Recall, the most serious type, due to the potential for serious injury or death. This update follows an earlier alert regarding issues with the devices.

The recall specifically affects the ENROUTE Transcarotid Neuroprotection System (NPS) and ENROUTE Transcarotid Neuroprotection System Plus (NPS Plus). These devices may also be found in hospital inventory systems associated with Silk Road Medical. A Class I recall signifies that there is a reasonable probability that using these products will cause serious adverse health consequences or death.

"This recall involves removing certain devices from where they are used or sold," the FDA said, emphasizing the critical nature of the action. Customers in the U.S. with questions, adverse reactions, or quality problems related to this issue should contact Boston Scientific directly at BSCFieldActionCenter@bsci.com or 1-763-415-7708.