Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation has recalled 219 units of the Lotus Edge Valve System (23mm model, reference H749LVSUS230) used in heart valve replacement procedures. The recall affects devices with expiration dates ranging from November 2, 2020 through October 29, 2021. These devices were distributed to hospitals and medical facilities across 40 U.S. states, the District of Columbia, and to government entities, as well as internationally to countries including Canada, Australia, Japan, and various European nations.
The recall was initiated because improper visual inspection prior to locking the valve during deployment can prevent the delivery system from being released from the patient. The recall record does not specify a remedy or instructions for what affected consumers should do.
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: 219 devices Lot/code info: GTIN 08714729960904. 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.