Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 08714729940814, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation has recalled 207 units of the Lotus Edge Valve System (23mm, model H749LVS230) used for transcatheter aortic valve replacement. The devices were distributed across 41 U.S. states, the District of Columbia, and multiple foreign countries including Canada, Australia, Japan, and several European nations. All unexpired lots with expiration dates between November 2, 2020 and October 29, 2021 are affected.
The recall was initiated because failure to properly execute a visual inspection before locking the valve during deployment could prevent the delivery system from being released. The record does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
Reason for recall: Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system. Distribution: Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. Government distribution was also made. Foreign distribution was made to Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Italy, Japan, Luxembourg, Netherlan Quantity: 207 devices Lot/code info: GTIN 08714729940814, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.