Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 08714729960928, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 302 units of the Lotus Edge Valve System, a transcatheter aortic valve prosthesis model 27mm (REF H749LVSUS270). The devices were distributed across 37 U.S. states, the District of Columbia, and multiple foreign countries including Canada, Australia, and several European nations. The affected devices have expiration dates ranging from November 2, 2020 through October 29, 2021.
The recall was issued because failure to correctly perform a visual inspection before locking the valve during deployment can result in the inability to release the delivery system. The recall record does not specify a remedy or action for affected consumers to take.
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: 302 devices Lot/code info: GTIN 08714729960928, 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.