Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation recalled 278 units of the Lotus Edge Valve System (25mm, model H749LVS250) manufactured in Ireland. The recalled devices were distributed across 40 U.S. states, Washington D.C., government agencies, and multiple foreign countries including Canada, Australia, Japan, and most of Western Europe. All unexpired lots with expiration dates between November 2, 2020 and October 29, 2021 are affected.
The reason for the recall is that failure to properly execute a visual inspection prior to locking the valve during deployment can result in the inability to release the delivery system from the valve. The recall notice does not specify a remedy or instructions for 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: 278 devices Lot/code info: GTIN 08714729940821, 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.