Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation recalled 386 units of the Lotus Edge Valve System, a transcatheter aortic valve prosthesis (Model H749LVS270, 27mm) manufactured in Ireland. The recall affects devices with expiration dates ranging from November 2, 2020, through October 29, 2021. These devices were distributed across 39 U.S. states, the District of Columbia, government facilities, and multiple international locations including Australia, Canada, Japan, and several European countries.
The reason for the recall is that failure to execute the visual inspection correctly before locking the valve during deployment can result in the inability to release the delivery system. The source document does not specify a remedy or required 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: 386 devices Lot/code info: GTIN 08714729940838, 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.